Opioid overdose monitoring

ABSTRACT

An overdose of opioids can cause the user to stop breathing, resulting in death. A physiological monitoring system monitors respiration based on oxygen saturation readings from a fingertip pulse oximeter in communication with a smart mobile device and sends opioid monitoring information from the smart mobile device to an opioid overdose monitoring service. The opioid overdose monitoring service notifies a first set of contacts when the opioid monitoring information.

FIELD

The present disclosure relates generally to the field of detecting anopioid overdose, and in particular, to detecting low saturation ofoxygen in the blood of an opioid user, and automatically notifying aresponder.

BACKGROUND

Substance abuse disorders impact the lives of millions of people. Anopioid overdose can occur when a person overdoses on an illicit opioiddrug, such as heroin or morphine. Many controlled substances areprescribed by physicians for medical use. Patients can accidentally takean extra dose or deliberately misuse a prescription opioid. Mixing aprescription opioid with other prescription drugs, alcohol, orover-the-counter-medications can cause an overdose. Children areparticularly susceptible to accidental overdoses if they take medicationthat is not intended for them. Opioid overdose is life-threatening andrequires immediate emergency attention.

SUMMARY

An opioid overdose is toxicity due to an excess or opioids. Symptoms ofan opioid overdose include marked confusion, delirium, or acting drunk;frequent vomiting; pinpoint pupils; extreme sleepiness, or the inabilityto wake up; intermittent loss of consciousness; breathing problems,including slowed or irregular breathing; respiratory arrest (absence ofbreathing); respiratory depression (a breathing disorder characterizedby slow and ineffective breathing); and cold, clammy skin, or bluishskin around the lips or under the fingernails.

Depressed breathing is the most dangerous side effect of opioidoverdose. Lack of oxygen to the brain can not only result in permanentneurologic damage, but may also be accompanied by the widespread failureof other organ systems, including the heart and kidneys. If a personexperiencing an opioid overdose is left alone and asleep, the personcould easily die as their respiratory depression worsens.

Oximetry can be used to detect depressed breathing. Oximetry utilizes anoninvasive optical sensor to measure physiological parameters of aperson. In general, the sensor has light emitting diodes (LEDs) thattransmit optical radiation into a tissue site and a detector thatresponds to the intensity of the optical radiation after absorption(e.g., by transmission or transreflectance) by, for example, pulsatilearterial blood flowing within the tissue site. Based on this response, aprocessor can determine measurements for peripheral oxygen saturation(SpO₂), which is an estimate of the percentage of oxygen bound tohemoglobin in the blood, pulse rate, plethysmograph waveforms, whichindicate changes in the volume of arterial blood with each pulse beat,and perfusion quality index (e.g., an index that quantifies pulsestrength at the sensor site), among many others.

It is noted that “oximetry” as used herein encompasses its broadordinary meaning known to one of skill in the art, which includes atleast those noninvasive procedures for measuring parameters ofcirculating blood through spectroscopy. Moreover, “plethysmograph” asused herein (commonly referred to as “photoplethysmograph”), encompassesits broad ordinary meaning known to one of skill in the art, whichincludes at least data representative of a change in the absorption ofparticular wavelengths of light as a function of the changes in bodytissue resulting from pulsing blood.

An oximeter that is compatible with a hand held monitor, such as amobile computing device, can be used to monitor physiologicalparameters. The oximeter can detect decreased oxygen saturation in theblood of the user. Decreased oxygen saturation in the blood of the useris an indication of respiratory distress, which can be an indication ofopioid overdose. Once the oxygen saturation of the user falls below anacceptable threshold, a software application in the mobile computingdevice can alert others to provide emergency help. The threshold can beset to provide an early indication of an overdose event. If the overdoseis caught early, emergency treatment can be provided before irreparableharm occurs.

A system to monitor for indications of opioid overdose and to delivertherapeutic drugs can comprise a sensor wearable by a user configured toobtain data indicative of at least one physiological parameter of theuser; a signal processor configured to process the data to provide theat least one physiological parameter; and a drug delivery apparatuswearable by the user and configured to deliver one or more doses of atherapeutic drug. The drug delivery apparatus can comprise a deliverydevice that includes a dose of a therapeutic drug stored in a reservoir,a drug delivery channel, a dispensing device to dispense the therapeuticdrug from the reservoir through the drug delivery channel, andactivation circuitry to activate the dispensing device.

The system can further comprise a medical monitoring hub configured tomonitor the at least one physiological parameter. The medical monitoringhub can comprise memory storing instructions and one or more computerprocessors configured to execute the instructions to at least comparethe at least one physiological parameter to a threshold that isindicative of opioid overdose; determine that an overdose event isoccurring or likely to occur based on the comparison; and send at leastone activation signal to the drug delivery apparatus to dispense atleast one dose of the therapeutic drug based on the determination.

The one or more computer processors of the medical monitoring hub can befurther configured to provide an alarm in response to determining thatthe overdose event is occurring or likely to occur; wait a period oftime after providing the alarm before sending the at least oneactivation signal; where receiving user input during the period of timestops the sending of the at least one activation signal. The one or morecomputer processors of the medical monitoring hub can be furtherconfigured to receive an indication of medical distress of the user; andsend a notification of the medical distress to one or more contacts,wherein the one or more contacts include medical professionals,relatives, friends, and neighbors.

The system can further comprise a housing that houses the sensor, thesignal processor, and the drug delivery device. The drug deliveryapparatus can further include a first antenna and a first processor incommunication with the first antenna, where the sensor can furtherinclude a second antenna and a second processor in communication withthe second antenna, and where the first and second processors can beconfigured to provide wireless communication between the drug deliverydevice and the sensor. The drug delivery apparatus can be a single usedrug delivery apparatus. The drug delivery device can further include anantenna to receive an activation signal. The drug delivery apparatus caninclude at least two drug delivery devices.

The medical monitoring hub can be in communication with a remote servercomprising a user database, memory storing instructions, and one or morecomputing devices configured to execute the instructions to cause theremote server to access user information associated with the user in theuser database. The user information can include contact information ofcontacts to notify with overdose status of the user.

The one or more computing devices of the remote server can be furtherconfigured to send notification of the overdose event to at least onecontact. The notification can include one or more of a location of theuser, a location of an opioid receptor antagonist drug, and anindication of the at least one physiological parameter. The notificationcan be one or more of a text message, an email, a message on socialmedia, and a phone call.

The system can further comprise a smart device in communication with thesignal processor to receive the at least one physiological parameter andin communication with the medical monitoring hub. The smart device cancomprise memory storing instructions, and one or more microprocessorsconfigured to execute the instructions to at least compare the at leastone physiological parameter to the threshold that is indicative ofopioid overdose; determine that the overdose event is occurring orlikely to occur based on the comparison; determine that the medicalmonitoring hub failed to send the at least one activation signal; andsend the at least one activation signal to the drug delivery apparatusto dispense at least one dose of the therapeutic drug in response to thedetermination that that the medical monitoring hub failed to send the atleast one activation signal. The memory of the smart device can furtherstore the contact information and the one or more microprocessors of thesmart device can be further configured to notify the contacts of theoverdose event.

The drug delivery apparatus can comprises a patch and can include anadhesive layer for adhesion to the user. The at least one physiologicalparameter can comprise one or more of oxygen saturation, heart rate,respiration rate, pleth variability, and perfusion index. The medicalmonitoring hub can further comprise an input to receive user input, aspeaker, and alarm circuitry, and where the one or more computerprocessors of the medical monitoring hub can be further configured toproduce an alarm based on the determination. Volume of the alarm canincrease until user input is received. A kit can comprising any of thesystems disclosed herein.

A medical monitoring hub to monitor for indications of opioid overdosecan comprise memory storing instructions and one or more computerprocessors configured to execute the instructions to at least receivedata indicative of at least one physiological parameter of a user thatis obtained by a user-wearable sensor; process the data to provide theat least one physiological parameter; compare the at least onephysiological parameter to a threshold that is indicative of opioidoverdose; determine that an overdose event is occurring or likely tooccur based on the comparison; and send at least one activation signalto a drug delivery apparatus to dispense at least one dose of thetherapeutic drug based on the determination. The drug delivery apparatuswearable by the user can be configured to deliver one or more doses of atherapeutic drug.

The drug delivery apparatus can comprises a delivery device thatincludes a dose of a therapeutic drug stored in a reservoir, a drugdelivery channel, a dispensing device to dispense the therapeutic drugfrom the reservoir through the drug delivery channel, and activationcircuitry to activate the dispensing device. The drug delivery apparatuscan comprise one or more delivery devices. Each drug delivery device cancomprise a dose of a therapeutic drug stored in a reservoir, a drugdelivery channel, a dispensing device to dispense the therapeutic drugfrom the reservoir through the drug delivery channel, activationcircuitry to activate the dispensing device, and an antenna to receivethe at least one activation signal. Each antenna can be tuned to receivea corresponding activation signal at a different frequency. The one ormore computer processors can be further configured to send two or moreactivation signals. Each of the two or more activation signals can havethe different frequencies to cause corresponding two or more activationcircuitry to activate to dispense two or more doses of the therapeuticdrug at approximately the same time.

A method to monitor for indications of opioid overdose and to delivertherapeutic drugs can comprise obtaining, from a sensor wearable by auser, data indicative of at least one physiological parameter of theuser; processing, with a signal processor, the data to provide the atleast one physiological parameter; and delivering, from a drug deliveryapparatus wearable by the user, one or more doses of a therapeutic drug.The delivering can comprise activating a dispensing device that isconfigured to dispense through a drug delivery channel a dose oftherapeutic drug stored in a reservoir; and dispensing with theactivated dispensing device, the dose of the therapeutic drug from thereservoir through the drug delivery channel.

The method can further comprise monitoring, with a medical monitoringhub that can comprise one or more computing devices, the at least onephysiological parameter. The monitoring can comprise comparing the atleast one physiological parameter to a threshold that is indicative ofopioid overdose; determining that an overdose event is occurring orlikely to occur based on the comparison; and sending at least oneactivation signal to the drug delivery apparatus to activate thedispensing device based on the determination. The method can furthercomprise providing an alarm in response to determining that the overdoseevent is occurring or likely to occur; and waiting a period of timeafter providing the alarm before sending the at least one activationsignal, where receiving user input during the period of time can stopthe sending of the at least one activation signal. The method canfurther comprise receiving an indication of medical distress of theuser; and sending a notification of the medical distress to one or morecontacts, wherein the one or more contacts include medicalprofessionals, relatives, friends, and neighbors.

The sensor, the signal processor, and the drug delivery device can behoused in a single housing. The drug delivery apparatus can furtherinclude a first antenna and a first processor in communication with thefirst antenna, where the sensor can further include a second antenna anda second processor in communication with the second antenna. The firstand second processors can be configured to provide wirelesscommunication between the drug delivery device and the sensor. The drugdelivery apparatus can be a single use drug delivery apparatus. The drugdelivery device can further include an antenna to receive an activationsignal. The drug delivery apparatus can include at least two drugdelivery devices.

The medical monitoring hub can be in communication with a remote serverthat can comprise a user database, memory storing instructions, and oneor more computing devices configured to execute the instructions tocause the remote server to access user information associated with theuser in the user database. The user information can include contactinformation of contacts to notify with overdose status of the user.

The method can further comprise sending, with the remote server,notification of the overdose event to at least one contact. Thenotification can include one or more of a location of the user, alocation of an opioid receptor antagonist drug, and an indication of theat least one physiological parameter. The notification can be one ormore of a text message, an email, a message on social media, and a phonecall.

A smart device can be in communication with the signal processor toreceive the at least one physiological parameter and can be incommunication with the medical monitoring hub. The smart device cancomprise memory storing instructions, and one or more microprocessorsconfigured to execute the instructions to at least compare the at leastone physiological parameter to the threshold that is indicative ofopioid overdose; determine that the overdose event is occurring orlikely to occur based on the comparison; determine that the medicalmonitoring hub failed to send the at least one activation signal; andsend the at least one activation signal to the drug delivery apparatusto dispense at least one dose of the therapeutic drug in response to thedetermination that that the medical monitoring hub failed to send the atleast one activation signal. The memory of the smart device can furtherstore the contact information and the one or more microprocessors of thesmart device are can be further configured to notify the contacts of theoverdose event.

The drug delivery apparatus can comprise a patch and can include anadhesive layer for adhesion to the user. The at least one physiologicalparameter can comprise one or more of oxygen saturation, heart rate,respiration rate, pleth variability, and perfusion index. The medicalmonitoring hub can further comprise an input to receive user input, aspeaker, and alarm circuitry, where the one or more computer processorsof the medical monitoring hub can be further configured to produce analarm based on the determination. The method can further comprisesincreasing volume of the alarm until user input is received.

A method to monitor for indications of opioid overdose can comprisereceiving data indicative of at least one physiological parameter of auser that is obtained by a user-wearable sensor; processing the data toprovide the at least one physiological parameter; comparing the at leastone physiological parameter to a threshold that is indicative of opioidoverdose; determining that an overdose event is occurring or likely tooccur based on the comparison; and sending at least one activationsignal to a drug delivery apparatus to dispense at least one dose of atherapeutic drug based on the determination. The drug delivery apparatuswearable by the user can be configured to deliver one or more doses ofthe therapeutic drug.

The drug delivery apparatus can comprise a delivery device that includesa dose of a therapeutic drug stored in a reservoir, a drug deliverychannel, a dispensing device to dispense the therapeutic drug from thereservoir through the drug delivery channel, and activation circuitry toactivate the dispensing device. The drug delivery apparatus can compriseone or more delivery devices. Each drug delivery device can comprise adose of a therapeutic drug stored in a reservoir, a drug deliverychannel, a dispensing device to dispense the therapeutic drug from thereservoir through the drug delivery channel, activation circuitry toactivate the dispensing device, and an antenna to receive the at leastone activation signal.

The method can further comprise sending two or more activation signals,where each antenna can be tuned to receive a corresponding activationsignal at a different frequency, and where each of the two or moreactivation signals can have the different frequencies to causecorresponding two or more activation circuitry to activate to dispensetwo or more doses of the therapeutic drug at approximately the sametime.

A system to monitor a user for an opioid overdose event can comprisesoftware instructions storable on a memory of a mobile computing devicethat includes one or more hardware processors, a touchscreen display,and a microphone. The software instructions can cause the one or morehardware processors to receive sounds from the microphone; determine anopioid overdose event is occurring or will soon occur based on thereceived sounds; present a request for user input on the touchscreendisplay based on the determination; and transmit wirelesslynotifications of the opioid overdose event to one or more recipientsbased on a failure to receive user input.

The mobile computing device can further comprise a camera, and the oneor more hardware processors can be further configured to receive imagesfrom the camera, and determine the opioid overdose event is occurring orwill soon occur based on the received sounds and images. The one or morehardware processors can be further configured to receive monitoring datafrom a monitoring service that monitors the user and an environmentlocal to the user; and transmit the notification of the opioid overdoseevent to the monitoring service. The monitoring service can be asecurity alarm service.

The monitoring data can include user data associated with a state of theuser and environmental data associated with the environment local to theuser. The one or more recipients can include friends and family havingcontact information stored in the memory of the mobile computing device.The one or more recipients can include one or more of a first responder,an emergency service, a local fire station, an ambulance service, arehabilitation center, an addiction treatment center, and a ridesharenetwork. The notification can include one or more of a text message, aphone call, and an email. The notification can include directions to alocation of the mobile computing device.

The one or more hardware processors can further analyze representationsof the sounds from the microphone to determine respiratory distress ofthe user local to the mobile computing device. The one or more hardwareprocessors can further analyze representations of the images from thecamera to determine respiratory distress of the user in the images. Theone or more hardware processors can further analyze representations ofthe images from the camera to determine an unconscious state of the userin the images. The one or more processors further can cause thetouchscreen display to display care instructions to care for a victim ofan opioid overdose.

The mobile computing device can further comprise a speaker and the oneor more hardware processors further can cause the speaker to output anaudible alarm based on the determination. The one or more hardwareprocessors can further cause the touchscreen display to flash, cause thetouchscreen display to display directions to a location of the mobilecomputing device, or cause a speaker of the mobile computing to provideaudible directions to the location of the user.

A system to monitor a user for an opioid overdose event can comprisesoftware instructions storable on a memory of a mobile computing devicethat includes one or more hardware processors, a touchscreen display,and a camera, the software instructions causing the one or more hardwareprocessors to receive images from the camera; determine an opioidoverdose event is occurring or will soon occur based on the receivedimages; present a request for user input on the touchscreen displaybased on the determination; and transmit wirelessly notifications of theoverdose event to one or more recipients based on a failure to receiveuser input.

The one or more hardware processors can be further configured to receivemonitoring data from a monitoring service that monitors the user and anenvironment local to the user; and transmit the notification of theopioid overdose event to the monitoring service. The monitoring servicecan be a security alarm service. The monitoring data can include userdata associated with a state of the user and environmental dataassociated with the environment local to the user. The one or morerecipients can include friends and family having contact informationstored in the memory of the mobile computing device. The one or morerecipients can include one or more of a first responder, an emergencyservice, a local fire station, an ambulance service, a rehabilitationcenter, an addiction treatment center, and a rideshare network. Thenotification can include one or more of a text message, a phone call,and an email. The notification can include directions to a location ofthe mobile computing device.

The one or more hardware processors can further analyze representationsthe sounds from the microphone to determine respiratory distress of theuser local to the mobile computing device. The one or more hardwareprocessors can further analyze representations of the images from thecamera to determine respiratory distress of the user in the images. Theone or more hardware processors can further analyze representations ofthe images from the camera to determine an unconscious state of the userin the images. The one or more processors further can cause thetouchscreen display to display care instructions to care for a victim ofan opioid overdose. The mobile computing device can further comprise aspeaker and the one or more hardware processors further can cause thespeaker to output an audible alarm based on the determination. The oneor more hardware processors can further cause the touchscreen display toflash, cause the touchscreen display to display directions to a locationof the mobile computing device, or cause a speaker of the mobilecomputing to provide audible directions to the location of the user.

A system to monitor a user for an opioid overdose event can comprise oneor more sensors configured to sense indications of an overdose conditionof a user from an environment local to the user; and a mobile computingdevice comprising a touchscreen display, memory storing softwareinstructions, and one or more hardware processors configured to executethe software instructions to at least receive the sensed indicationsfrom the one or more sensors; determine an opioid overdose event isoccurring or will soon occur based on the received indications; presenta request for user input on the touchscreen display based on thedetermination; and transmit wirelessly notifications of the overdoseevent to one or more recipients based on a failure to receive userinput.

The one or more hardware processors can be further configured to receivemonitoring data from a monitoring service that monitors the user and anenvironment local to the user; and transmit the notification of theopioid overdose event to the monitoring service. The monitoring serviceis a security alarm service. The monitoring data can include user dataassociated with a state of the user and environmental data associatedwith the environment local to the user. The one or more recipients caninclude friends and family having contact information stored in thememory of the mobile computing device. The one or more recipients caninclude one or more of a first responder, an emergency service, a localfire station, an ambulance service, a rehabilitation center, anaddiction treatment center, and a rideshare network. The notificationcan include one or more of a text message, a phone call, and an email.The notification can include directions to a location of the mobilecomputing device.

The one or more hardware processors can further analyze representationsof the sounds from the microphone to determine respiratory distress ofthe user local to the mobile computing device. The one or more hardwareprocessors can further analyze representations of the images from thecamera to determine respiratory distress of the user in the images. Theone or more hardware processors can further analyze representations ofthe images from the camera to determine an unconscious state of the userin the images. The one or more processors further can cause thetouchscreen display to display care instructions to care for a victim ofan opioid overdose. The mobile computing device can further comprise aspeaker and the one or more hardware processors further can cause thespeaker to output an audible alarm based on the determination. The oneor more hardware processors can further cause the touchscreen display toflash, cause the touchscreen display to display directions to a locationof the mobile computing device, or cause a speaker of the mobilecomputing to provide audible directions to the location of the user.

A method to monitor a user for an opioid overdose event can comprisereceiving sounds from a microphone of a mobile computing device;determining, with one or more hardware processors of the mobilecomputing device, an opioid overdose event is occurring or will soonoccur based on the received sounds; presenting, with one or morehardware processors, a request for user input on a touchscreen displayof the mobile computing device, the request based on the determination;and transmitting wirelessly, with the mobile computing device,notifications of the overdose event to one or more recipients based on afailure to receive user input.

The method can further comprise receiving images from a camera of themobile computing device; and determining, with the one or more hardwareprocessors of the mobile computing device, the opioid overdose event isoccurring or will soon occur based on the received sounds and images.The method can further comprise receive monitoring data from amonitoring service that monitors the user and an environment local tothe user; and transmit the notification of the opioid overdose event tothe monitoring service. The monitoring service is a security alarmservice. The monitoring data can include user data associated with astate of the user and environmental data associated with the environmentlocal to the user. The one or more recipients can include friends andfamily having contact information stored in the memory of the mobilecomputing device. The one or more recipients can include one or more ofa first responder, an emergency service, a local fire station, anambulance service, a rehabilitation center, an addiction treatmentcenter, and a rideshare network. The notification can include one ormore of a text message, a phone call, and an email. The notification caninclude directions to a location of the mobile computing device.

The method can further comprise analyzing representations of the soundsfrom the microphone to determine respiratory distress of the user localto the mobile computing device. The method can further compriseanalyzing representations of the images from the camera to determinerespiratory distress of the user in the images. The method can furthercomprise analyzing representations of the images from the camera todetermine an unconscious state of the user in the images. The method canfurther comprise causing the touchscreen display to display careinstructions to care for a victim of an opioid overdose. The method canfurther comprise outputting, from the mobile computing device, anaudible alarm based on the determination.

The method can further comprise causing the touchscreen display toflash, cause the touchscreen display to display directions to a locationof the mobile computing device, or cause a speaker of the mobilecomputing to provide audible directions to the location of the user.

A method to monitor a user for an opioid overdose event can furthercomprise receiving images from a camera of a mobile computing device;determining, with one or more hardware processors of the mobilecomputing device, an opioid overdose event is occurring or will soonoccur based on the received images; presenting, with one or morehardware processors, a request for user input on a touchscreen displayof the mobile computing device, the request based on the determination;and transmitting wirelessly, with the mobile computing device,notifications of the overdose event to one or more recipients based on afailure to receive user input.

The method can further comprise receiving monitoring data from amonitoring service that monitors the user and an environment local tothe user; and transmitting the notification of the opioid overdose eventto the monitoring service. The monitoring service can be a securityalarm service. The monitoring data can include user data associated witha state of the user and environmental data associated with theenvironment local to the user. The one or more recipients can includefriends and family having contact information stored in the memory ofthe mobile computing device. The one or more recipients can include oneor more of a first responder, an emergency service, a local firestation, an ambulance service, a rehabilitation center, an addictiontreatment center, and a rideshare network. The notification can includeone or more of a text message, a phone call, and an email. Thenotification can include directions to a location of the mobilecomputing device. The method can further comprise analyzingrepresentations the sounds from the microphone to determine respiratorydistress of the user local to the mobile computing device.

A method to monitor a user for an opioid overdose event can comprisereceiving sensed indications of an overdose condition of a user from oneor more sensors configured to sense an environment local to the user;determine an opioid overdose event is occurring or will soon occur basedon the received indications; present a request for user input on thetouchscreen display based on the determination; and transmit wirelesslynotifications of the overdose event to one or more recipients based on afailure to receive user input.

The method can further comprise receiving monitoring data from amonitoring service that monitors the user and an environment local tothe user; and transmitting the notification of the opioid overdose eventto the monitoring service. The monitoring service can be a securityalarm service. The monitoring data can include user data associated witha state of the user and environmental data associated with theenvironment local to the user. The method can further comprise analyzingrepresentations of the images from the camera to determine respiratorydistress of the user in the images.

The method can further comprise analyzing representations of the imagesfrom the camera to determine an unconscious state of the user in theimages. The method can further comprise causing the touchscreen displayto display care instructions to care for a victim of an opioid overdose.The method can further comprise outputting, from the mobile computingdevice, an audible alarm based on the determination.

A system to monitor for indications of opioid overdose event cancomprise software instructions storable in memory of a first mobilecomputing device. The software instructions executable by one or morehardware processors of the first mobile computing device can cause theone or more hardware processors to continuously receive data indicativeof one or more physiological parameters of a first user that is beingmonitored by one or more sensors; continuously compare each of the oneor more physiological parameters with a corresponding threshold;determine an opioid overdose event is occurring or will soon occur basedon the comparisons; trigger an alarm on the first mobile computingdevice based on the determination; and notify a second user of the alarmby causing a display of a second mobile computing device associated withthe second user to display a status of an alarming physiologicalparameter of the first user.

The one or more hardware processors can further cause a display of thefirst mobile computing device to continuously update graphicalrepresentations of the one or more physiological parameters in responseto the continuously received data. The one or more hardware processorscan further display a user-selectable input to view additionalinformation associated with the first user.

Selecting the user-selectable input can cause the display of the secondmobile computing device to display one or more of trends and currentvalue of the alarming physiological parameter. Selecting theuser-selectable input can cause the display of the second mobilecomputing device to display a location of the first mobile computingdevice on a map. Selecting the user-selectable input can cause thedisplay of the second mobile computing device to display a time of aninitial alarm. Selecting the user-selectable input can cause the displayof the second mobile computing device to provide access to directions tothe first mobile computing device from a location of the second mobilecomputing device. Selecting the user-selectable input can cause thedisplay of the second mobile computing device to provide access to callthe first mobile computing device.

The one or more physiological parameters can be represented as dials onthe display. The one or more physiological parameters can include one ormore of oxygen saturation, heart rate, respiration rate, plethvariability, perfusion index, and respiratory effort index. The alarmcan be an audible and visual alarm. Each of the corresponding thresholdscan be adjustable based on characteristics of the first user to inhibitfalse-positive alarms.

The one or more hardware processors can further transmit indications ofthe one or more physiological parameters to a remote server. The one ormore hardware processors can further transmit indications of the one ormore physiological parameters to a medical monitoring hub for storage inmemory of the medical monitoring hub. The one or more hardwareprocessors can communicate wirelessly with a local Internet of Thingsconnected device to receive additional data for use in the determinationof the opioid overdose event. The one or more hardware processors canfurther notify emergency services of the alarm. The first and secondmobile computing devices can be smart phones.

A method to monitor for indications of an opioid overdose event cancomprise continuously receiving, with a first mobile computing device,data indicative of one or more physiological parameters of a first userthat is being actively monitored by one or more sensors; continuouslycomparing, with the first mobile computing device, each of the one ormore physiological parameters with a corresponding threshold;determining, with the first mobile computing device, an opioid overdoseevent is occurring or will soon occur based on the comparisons;triggering, with the first mobile computing device, an alarm on thefirst mobile computing device based on the determination; and notifying,with the first mobile computing device, a second user of the alarm bycausing a display of a second mobile computing device associated withthe second user to display a status of an alarming physiologicalparameters of the first user.

The method can further comprise causing a display of the first mobilecomputing device to continuously update graphical representations of theone or more physiological parameters in response to the continuouslyreceived data. The method can further comprising displaying auser-selectable input to view additional information associated with thefirst user.

Selecting the user-selectable input can cause the display of the secondmobile computing device to display one or more of trends and currentvalue of the alarming physiological parameter. Selecting theuser-selectable input can cause the display of the second mobilecomputing device to display a location of the first mobile computingdevice on a map. Selecting the user-selectable input can cause thedisplay of the second mobile computing device to display a time of aninitial alarm. Selecting the user-selectable input can cause the displayof the second mobile computing device to provide access to directions tothe first mobile computing device from a location of the second mobilecomputing device. Selecting the user-selectable input can cause thedisplay of the second mobile computing device to provide access to callthe first mobile computing device.

The one or more physiological parameters can be represented as dials onthe display. The one or more physiological parameters can include one ormore of oxygen saturation, heart rate, respiration rate, plethvariability, perfusion index, and respiratory effort index. The alarmcan be an audible and visual alarm. Each of the corresponding thresholdscan be adjustable based on characteristics of the first user to inhibitfalse-positive alarms.

The method can further comprise transmitting indications of the one ormore physiological parameters to a remote server. The method can furthercomprise transmitting indications of the one or more physiologicalparameters to a medical monitoring hub for storage in memory of themedical monitoring hub. The method can further comprise communicatingwirelessly with a local Internet of Things connected device to receiveadditional data for use in the determination of the opioid overdoseevent. The method can further comprise notifying emergency services ofthe alarm. The first and second mobile computing devices can be smartphones.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features are discussed herein. It is to be understood that notnecessarily all such aspects, advantages or features will be embodied inany particular embodiment of the invention, and an artisan wouldrecognize from the disclosure herein a myriad of combinations of suchaspects, advantages or features.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments will be described hereinafter with reference to theaccompanying drawings. The drawings and the associated descriptions areprovided to illustrate embodiments of the present disclosure and do notlimit the scope of the claims. In the drawings, similar elements havesimilar reference numerals.

FIG. 1A is an overview of an example opioid use monitoring system.

FIG. 1B is a diagrammatic representation of an example networkassociated with monitoring opioid.

FIG. 1C is an overview of another example opioid use monitoring system.

FIG. 2A is a block diagram of an example physiological monitoringsystem.

FIG. 2B is a flow chart of an example process to monitor physiologicalparameters for opioid use and provide notifications.

FIGS. 3A-3E illustrate various example software applications to provideinformation, notifications, and alerts to opioid users, firstresponders, medical personnel, and friends.

FIG. 4 is a flow chart of an example process to monitor for opioidoverdose.

FIGS. 5A-5F illustrate various example software applications to triggeran alarm and notify a friend when an opioid overdose is indicated.

FIGS. 6A-6J illustrate various examples of physiological parametersensors and signal processing devices.

FIG. 7A is a block diagram of an example opioid user system environmentand an example cloud environment.

FIG. 7B is a block diagram illustrating example components of a cloudenvironment.

FIG. 7C is a block diagram illustrating example components of an opioiduser system of an example opioid user system environment.

FIG. 8 is a flowchart of an example process to notify an opioid user'snotification network of the status of the opioid user.

FIG. 9A is a block diagram of an example physiological monitoring andmedication administration system.

FIGS. 9B and 9C are schematic diagrams of example self-administratingmedication applicators.

FIG. 10 is a flow diagram of an example process to monitor for opioidoverdose and to apply medication to reverse the effects of an overdose.

FIGS. 11A-11C are schematic diagrams of example needle-free injectionmulti-dose self-administrating medication applicators.

FIGS. 12A and 12B are schematic diagrams of example injection multi-doseself-administrating medication applicators having a hypodermic needlefor injection.

FIG. 13 is a schematic diagram of an example wearableself-administrating medication applicator.

FIG. 14 is a block diagram of example activation circuitry formulti-dose self-administrating medication applicators.

FIG. 15 is a flow diagram of an example process to administer medicationfrom a self-administrating medication applicator.

FIGS. 16A and 16B are flow diagrams of example processes to administermultiple doses of medication from a self-administrating medicationapplicator.

FIG. 17 is a schematic diagram of another example wearableself-administrating medication applicator.

FIG. 18A is a block diagram of an example opioid use monitoring system.

FIGS. 18A1-18A25 illustrate various example software applications totrigger an alarm and notify a friend when an opioid overdose isindicated.

FIG. 18B is a flow diagram of an example process to administer theopioid receptor antagonist using the system of FIG. 18A.

FIG. 19 is an example of a medical monitoring hub device used on theopioid use monitoring system of FIG. 18.

FIGS. 20A and 20B are schematic diagrams of example prescription andnon-prescription opioid overdose monitoring kits.

DETAILED DESCRIPTION

Although certain embodiments and examples are described below, thisdisclosure extends beyond the specifically disclosed embodiments and/oruses and obvious modifications and equivalents thereof. Thus, it isintended that the scope of this disclosure should not be limited by anyparticular embodiments described below.

Overview

An application for a mobile computing device that is used in conjunctionwith a physiological parameter monitoring assembly to detectphysiological parameters of an opioid user can comprise determining aphysiological condition of the opioid user based at least in part on thephysiological parameters, and providing notifications based at least inpart on the physiological condition of the opioid user. Thephysiological parameter monitoring assembly can be a pulse oximeter thatincludes a sensor and a signal processing device. Examples ofphysiological parameters that can be monitored are peripheral oxygensaturation (SpO₂), respiration, and perfusion index (PI). Theapplication can determine the physiological condition of the user basedon the SO₂ alone, respiration alone, PI alone, a combination of the SO₂and respiration, a combination of the SpO₂ and PI, a combination of therespiration and the PI, or a combination of the SpO₂, respiration, andPI.

The application can request user input and determine the physiologicalcondition of the user based at least in part on the received user inputand the physiological parameters from the pulse oximeter. Thedetermination of the user's condition can be based on the user input andone or more of peripheral oxygen saturation (SpO₂), respiration, andperfusion index (PI). The application can learn, based at least in parton stored physiological parameters, trends in user's the physiologicalreaction to opioid use to better anticipate overdose events of the user.

The application can notify one or more of caregivers, loved ones,friends, and first responders of an overdose event. The application canprovide “everything OK” notifications upon request or periodically toconcerned family and friends. The application can provide detailed careinstructions to first responders. The application can provide thelocation of the user, the location of the closest medication to reversethe effects of an opioid overdose, or the location of the closestmedical personnel. The application can provide one or more of visual,audible, and sensory (vibration) alerts to the user with increasingfrequency and intensity to the user.

An application for a mobile computing device that is used in conjunctionwith a sensor and a signal processing device to detect abnormally lowblood oxygen saturation that is indicative of an overdose event in auser can comprise triggering an alarm, and notifying others of theoverdose event. This increases the likelihood that opioid users, theirimmediate personal networks, and first responders are able to identifyand react to an overdose by administrating medication to reverse theeffects of the overdose. Such medication can be considered an opioidreceptor antagonist or a partial inverse agonist. Naloxone or Narcan® isa medication that reverses the effect of an opioid overdose and is anopioid receptor antagonist. Buprenorphine or Subutex® is an opioid usedto treat opioid addiction. Buprenorphine combined with naloxone orSuboxone® is a medication that may also be used to reverse the effect ofan opioid overdose. Other example medications are naltrexone,nalorphine, and levallorphan. Administration can be accomplished byintravenous injection, intramuscular injection, and intranasally, wherea liquid form of the medication is sprayed into the user's nostrils.Administration of the medication can also occur via an endotrachealtube, sublingually, where a gel or tablet of the medication is appliedunder the tongue, and transdermally, where the medication can be a gelapplied directly to the skin or within a transdermal patch applied tothe skin.

A system to monitor a user for an opioid overdose condition can comprisea sensor configured to monitor one or more physiological parameters of auser, a signal processing device configured to receive raw datarepresenting the monitored one or more physiological parameters and toprovide filtered parameter data; and a mobile computing deviceconfigured to receive the one or more physiological parameters from thesignal processing device. The mobile computing device comprises a userinterface, a display, network connectivity, memory storing anapplication as executable code, and one or more hardware processors. Theapplication monitors the physiological parameters to determine acondition of the user and provides notifications to the user, to acrowd-sourced community of friends, family, and other opioid users thathave also downloaded the application onto their computing devices, andto emergency providers and medical care personnel.

Home pulse oximetry monitoring systems for opioid users can include apulse oximeter, such as a Masimo Rad-97 Pulse CO-Oximeter®, for example,and sensors, such as Masimo LNCS® adhesive sensors and the like, todetect blood oxygen levels and provide alerts and alarms when the opioiduser's blood oxygen level drops below a threshold. The home monitoringsystem can provide alarm notifications that can alert a family member,remote caregiver, and a first responder, for example, to awaken theopioid user and to administer the antidote for an opioid overdose, suchas an opioid receptor antagonist.

The mobile computing device can be configured to receive the filteredparameter data from the signal processing device; displayrepresentations of the filtered parameter data on the display, where thefiltered parameter data includes at least oxygen saturation data for theoxygen level in the blood of the user; compare a current oxygensaturation value to a minimum oxygen saturation level; trigger an alarmwhen the current oxygen saturation value is below the minimum oxygensaturation level; and provide notifications over a network to anotherwhen the current oxygen saturation value is below the minimum oxygensaturation level.

The display can display the representations of the filtered parameterdata as dials indicating acceptable and acceptable ranges. The filteredparameter data can include one or more of heart rate data, respirationrate data, pleth variability data, perfusion index data, and respiratoryeffort index data. The application can provide notifications to the userand can provide notifications to others. The notification can be one ormore of a text message, an email, and a phone call. The notification caninclude a current value of oxygen saturation and a graph indicting atrend of the oxygen saturation levels. The notification can furtherinclude one or more of a phone number of the user, a location of theuser, directions to the location of the user, a closest location ofnaloxone or other medication used to reverse the effects of an opioidoverdose. The notification can be an automatic call to emergencyresponders.

A system to monitor a user for an opioid overdose condition can compriseone or more computing devices associated with an opioid overdosemonitoring service. The opioid overdose monitoring service can beconfigured to identify opioid monitoring information from at least onephysiological monitoring system associated with a user, where the opioidmonitoring information comprises one of an overdose alert and anon-distress status, retrieve over a network notification informationassociated with the user, where the notification information includesfirst contact information associated with the overdose alert and secondcontact information associated with the non-distress status, send anoverdose notification using the first contact information in response tothe opioid monitoring information that indicates the overdose alert, andsend a non-distress notification using the second contact information inresponse to the opioid monitoring information that indicates thenon-distress status.

The system can further comprise a physiological monitoring systemcomprising a sensor configured to monitor one or more physiologicalparameters of the user and a signal processing board configured toreceive raw data representing the monitored one or more physiologicalparameters and to provide filtered parameter data, and a mobilecomputing device comprising a display, network connectivity, memorystoring executable code, and one or more hardware processors. The mobilecomputing device can be configured to receive the filtered parameterdata from the signal processing board, display representations of thefiltered parameter data on the display, where the filtered parameterdata includes at least oxygen saturation data for the oxygen level inthe blood of the user, compare a current oxygen saturation value to aminimum oxygen saturation level, and trigger an alarm when the currentoxygen saturation value is below the minimum oxygen saturation level.

The mobile computing device can be configured to receive the filteredparameter data from the signal processing board, generate the opioidmonitoring information based on the filtered parameter data, and sendthe opioid monitoring information over a network to the opioid overdosemonitoring service. The filtered parameter data can include one or moreof a current oxygen saturation value, heart rate data, respiration ratedata, pleth variability data, perfusion index data, and respiratoryeffort index data. The overdose and non-distress notifications cancomprise one or more of a text message, an email, and a phone call. Theoverdose and non-distress notifications can include a current value ofoxygen saturation and a graph indicting a trend of the oxygen saturationlevels. The overdose notification can comprise one or more of a phonenumber of the user, a location of the user, directions to the locationof the user, a closest location of naloxone or other medication used toreverse the effects of an opioid overdose. The overdose notification canautomatically calls emergency responders. The network can be theInternet.

A kit for monitoring for an opioid overdose event can comprise a sensorto sensor physiological parameters and a medical monitoring hub deviceto receive indications of the sensed physiological parameters and toreceive an indication of an opioid overdose event. The kit can furthercomprise a delivery device to deliver medication in response to theindication of the opioid overdose event. The delivery device canautomatically administers an opioid receptor antagonist in response tothe indication of an opioid overdose event. The delivery device cancomprise a patch that includes a reservoir with the medication, aneedle, and a battery. The hub device can comprise memory for storage ofthe indication of the sensed physiological parameters. The hub devicecan receive and store data from monitoring devices other than thesensor. The data from the monitoring devices can comprise dataassociated with a well-being of a user. The kit may be available withouta prescription.

FIG. 1A is an overview of an example opioid use monitoring/notificationsystem. The opioid users' support network can include friends, family,emergency services, care providers, and overdose care networks, forexample that communicate over a network, such as the Internet. Thesupport network receives notifications and/or status updates of theopioid user's condition. An optional monitoring device can monitor theopioid user's respiration and other biological parameters, such as heartrate, blood oxygen saturation, perfusion index, for example, andprovides the parameters to the smart device. An application running onthe smart device can determine whether an opioid overdose event isimminent and/or occurring. The application can also provide additionalinformation, such as care instructions, patient trends, medical opioidinformation, care instruction, user location, the location of naloxone,buprenorphine, buprenorphine in combination with naloxone, or othermedication used to reverse the effects of an opioid overdose, and thelike. The support network, after receiving a notification, cancommunicate with a central server to obtain the additional information.

FIG. 1B is a diagrammatic representation of an example support networkassociated with monitoring opioid use. The diagram illustrates anexample of an opioid use support network. An opioid user may want tonotify friends, family, and caregivers when they are in need ofemergency care due to indications that an opioid overdose is imminent oroccurring. The diagram illustrates an example of an opioid use supportnetwork. Subnetworks within the support network may receive differentnotifications. For example, caregivers, such as emergency 911 services,rideshare services, such as Uber® and Lyft®, for example, treatmentcenters, prescribing caregivers, specialty caregivers, ambulanceservices can receive possible overdose alerts in order to provide theimmediate life-saving care to the user; an on-site caregiver can receivecare instructions; friends and family can receive periodic statusmessages indicating no overdose event occurring; and transportationservices can receive messages with the location of medications used toreverse the effects of an opioid overdose, such as naloxone,buprenorphine, a combination of buprenorphine and naloxone, and thelike. Other subnetworks receiving different notifications are possible.

FIG. 1C is an overview of another example opioid use monitoring system.As illustrated above in FIG. 1A, the opioid users' support network caninclude friends, family, emergency services, care providers, andoverdose care networks, for example, that communicate over a network,such as the Internet. The support network receives notifications and/orstatus updates of the opioid user's condition. A monitoring deviceincluding a sensor can monitor the opioid user's respiration and otherbiological parameters, such as heart rate, blood oxygen saturation,perfusion index, for example, and provide the parameters to a HUB devicethat can communicate over the network. An example of a HUB device isillustrated in FIG. 6H. The HUB device receives the sensor data from thesensor. The HUB device can send the sensor data over the network to theserver. The HUB device can at least partially processes the sensor dataand sends that at least partially processed sensor data to the server.The server processes the sensor data or the at least partially processedsensor data and determines whether an overdose event is imminent and/oroccurring. When an overdose event is imminent and/or occurring, theserver notifies the support network and the mobile application on theopioid user's mobile device.

Instrumentation-Sensor and Signal Processing Device

FIG. 2A illustrates an example physiological monitoring system 100. Theillustrated physiological monitoring system 100 includes a sensor 102, asignal processing device 110, and a mobile computing device 120.

The sensor 102 and the signal processing device 110 can comprise a pulseoximeter. Pulse oximetry is a noninvasive method for monitoring aperson's oxygen saturation. The sensor 102 is placed on the user's bodyand passes two wavelengths of light through the body part to aphotodetector. The sensor 102 can provide raw data 104 to the signalprocessing device 110, which determines the absorbance's of the lightdue to pulsating arterial blood. The pulse oximeter generates ablood-volume plethysmograph waveform from which oxygen saturation ofarterial blood, pulse rate, and perfusion index, among otherphysiological parameters, can be determined, and provides physiologicalparameters 118 to the mobile computing device 120.

The pulse oximeter can be transmissive, where the sensor 102 is placedacross a thin part of the user's body, such as a fingertip or earlobe,for example, or reflective, where the sensor 102 can be placed on theuser's forehead, foot, or chest, for example.

The sensor 102 and the signal processing device 110 can be packagedtogether. The sensor 102 can be not packaged with the signal processingdevice 110 and communicates wirelessly or via a cable with the signalprocessing device 110.

Examples of pulse oximeters are the MIGHTYSAT RX fingertip pulseOximeter®, the Rad-57® handheld pulse CO-oximeter, and the Rainbow®CO-oximeter, all by Masimo Corporation, Irvine, Calif., which arecapable of being secured to a digit, such as a finger.

Because opioid users may want to be discrete when monitoring opioid usefor indications of an overdose event, sensors 102 that are not visiblemay provide additional confidentiality for the user. The sensor 102 canbe applied to a toe and the signal processing device 110 can comprise anankle brace. The sensor 102 can be a ring on the user's finger or abracelet on the user's wrist, and the signal processing device 110 canbe within an arm band hidden under the user's sleeve. The sensor 102 orthe sensor 102 and the signal processing device 110 can be integratedinto a fitness device worn on the user's wrist. Such pulse oximeters canbe reflective or transmissive. The sensor 102 can be an ear sensor thatis not readily visible.

Other varieties of sensors 102 can be used, for example adhesivesensors, combination reusable/disposable sensors, soft and/or flexiblewrap sensors, infant or pediatric sensors, multisite sensors, or sensorsshaped for measurement at a tissue site such as an ear.

Other sensors 102 can be used to measure physiological parameters of theuser. For example, a modulated physiological sensor can be a noninvasivedevice responsive to a physiological reaction of the user to an internalor external perturbation that propagates to a skin surface area. Themodulated physiological sensor has a detector, such as an accelerometer,configured to generate a signal responsive to the physiologicalreaction. A modulator varies the coupling of the detector to the skin soas to at least intermittently maximize the detector signal. A sensorprocessor controls the modulator and receives an effectively amplifieddetector signal, which is processed to calculate a physiologicalparameter indicative of the physiological reaction. A modulatedphysiological sensor and corresponding sensor processor are described inU.S. Publication No. 2013/0046204 to Lamego et al., filed Feb. 21, 2013,titled “MODULATED PHYSIOLOGICAL SENSOR” and assigned to MasimoCorporation, Irvine, Calif., which is hereby incorporated by referenceherein.

The sensor 102 can include an electroencephalograph (“EEG”) that can beconfigured to measure electrical activity along the scalp. The sensor102 can include a capnometer or capnograph that can be configured tomeasure components of expired breath.

An acoustic sensor 102 can be used to determine the user's respirationrate. An acoustic sensor utilizing a piezoelectric device attached tothe neck is capable of detecting sound waves due to vibrations in thetrachea due to the inflow and outflow of air between the lungs and thenose and mouth. The sensor outputs a modulated sound wave envelope thatcan be demodulated so as to derive respiration rate. An acousticrespiration rate sensor and corresponding sensor processor is describedin U.S. Publication No. 2011/0125060 to Telfort et al., filed Oct. 14,2010, titled “ACOUSTIC RESPIRATORY MONITORING SYSTEMS AND METHODS” andassigned to Masimo Corporation, Irvine, Calif., which is herebyincorporated by reference herein.

The mobile computing device 120 can include an accelerometer that isconfigured to detect motion of the mobile computing device 120. When theuser holds the mobile computing device 120 or attaches the mobilecomputing device 120 to his clothing in such a way that theaccelerometer detects motion of the user, then the accelerometer can beused to detect lack of motion of the user. The lack of user motion canbe used to determine the user's condition, as described below.

When the user holds the mobile computing device 120, the accelerometercan sense vibrations from the user indicative of the user's heart rate.A lack of vibrations sensed by the accelerometer can indicate no heartrate and reduced occurrences of vibrations sensed by the accelerometercan indicate cardiac distress. The indications of cardiac activitysensed by the accelerometer in the mobile computing device can be usedto determine the user's condition, as described below.

The sensor 102 can be a centroid patch worn by the user that includes anaccelerometer. Data indicative of the movement of the accelerometer canbe transmitted wirelessly to the mobile computing device 120. Based onmovement detected by the accelerometer, the application detects therespiration rate of the user. An oxygen sensor configured to monitor theuser's breath can wirelessly transmit an indication of the oxygenpresent in the user's exhaled breath.

The physiological sensor 102 and the mobile computing device 120 can beconnected via a cable or cables and the signal processing device 110 canbe connected between the sensor 102 and the mobile computing device 120to conduct signal processing of the raw data 104 before thephysiological parameters 118 are transmitted to the mobile computingdevice 120. A mobile physiological parameter monitoring system isdescribed in U.S. Pat. No. 9,887,650 to Muhsin et al., issued on Jan.30, 2018, titled “PHYSIOLOGICAL MONITOR WITH MOBILE COMPUTING DEVICECONNECTIVITY”, and assigned to Masimo Corporation, Irvine, Calif., whichis hereby incorporated by reference herein.

In various oximeter examples, the sensor 102 provides data 104 in theform of an output signal indicative of an amount of attenuation ofpredetermined wavelengths (ranges of wavelengths) of light by bodytissues, such as, for example, a digit, portions of the nose or ear, afoot, or the like. The predetermined wavelengths often correspond tospecific physiological parameter data desired, including for example,blood oxygen information such as oxygen content (SpOC), oxygensaturation (SpO₂), blood glucose, total hemoglobin (SbHb), methemoglobin(SbMet), carboxyhemoglobin (SpCO), bulk tissue property measurements,water content, pH, blood pressure, respiration related information,cardiac information, perfusion index (PI), pleth variability indices(PVI), or the like, which can be used by the mobile computing device 120to determine the condition of the user. Sensor data 104 can provideinformation regarding physiological parameters 118 such as EEG, ECG,heart beats per minute, acoustic respiration rate (RRa), breaths perminute, end-tidal carbon dioxide (EtCO₂), respiratory effort index,return of spontaneous circulation (ROSC), or the like, which can be usedto determine the physiological condition of the user.

Referring to FIG. 2A, the sensor 102 can transmit raw sensor data 104 tothe signal processing device 110, and the signal processing device 110can convert the raw sensor data 104 into data representing physiologicalparameters 118 for transmission to the mobile computing device 120 fordisplay, monitoring and storage. The sensor data 104 can be transmittedwirelessly, using Bluetooth®, near field communication protocols, Wi-Fi,and the like or the sensor data 104 can be transmitted to the signalprocessing device 110 through a cable.

The sensor data 104 can be corrupted by noise due to patient movement,electromagnetic interference, or ambient light, for example. Thephysiological parameter monitoring system 100 can apply noise filteringand signal processing to provide the physiological parameters 118 foranalysis and display on the mobile computing device 120. Such complexprocessing techniques can exceed the processing capabilities of themobile computing device 120, and therefore the signal processing device110 can handle signal processing of the raw sensor data 104 and transmitthe processed physiological parameters 118 to the mobile computingdevice 120.

In the context of pulse oximetry, the signal processing device 110 canuse adaptive filter technology to separate an arterial signal, detectedby a pulse oximeter sensor 102, from the non-arterial noise (e.g. venousblood movement during motion). During routine patient motions(shivering, waving, tapping, etc.), the resulting noise can be quitesubstantial and can easily overwhelm a conventional ratio based oximetrysystem. This can provide accurate blood oxygenation measurements evenduring patient motion, low perfusion, intense ambient light, andelectrocautery interference. Accordingly, false alarms can besubstantially eliminated without sacrificing true alarms.

The signal processing device 110 can transmit the physiologicalparameters 118 wirelessly, using Bluetooth®, near field communicationprotocols, Wi-Fi, and the like to the mobile computing device 120, orthe signal processing device 110 can transmit the physiologicalparameters 118 to the mobile computing device 120 through a cable.

FIGS. 6A-6J illustrate various example sensors 102 and signal processingdevices 110. FIG. 6A illustrates a mobile physiological monitoringsystem 610 that includes a fingertip pulse oximeter sensor 102 that isconnected to the mobile computing device 120, which is illustrated as asmartphone, through a cable that includes the signal processing device110.

FIGS. 6B-6D illustrate other example mobile physiological sensorassemblies that can be in physical communication with a user to collectthe user's physiological data and send indications of the user'sphysiological parameters to the mobile computing device 120. FIG. 6Billustrates a mobile physiological sensor assembly 620 that includes anelectroencephalograph (“EEG”) that can be configured to measureelectrical activity along the scalp. FIG. 6C illustrates a mobilephysiological sensor assembly 630 that includes a capnometer orcapnograph that can be configured to measure components of expiredbreath. FIG. 6D illustrates a mobile physiological sensor assembly 640that includes an acoustic respiratory monitor sensor that can beconfigured to measure respiration rate using an adhesive sensor with anintegrated acoustic transducer.

FIG. 6E illustrates the Rad-57® handheld pulse CO-oximeter 650 by MasimoCorporation, Irvine Calif. The oximeter 650 has a fingertip oximetersensor 102 that communicates the raw data 104 through a cable to thesignal processing device 110, which includes display capabilities.

FIG. 6F illustrates the MIGHTYSAT RX fingertip pulse Oximeter® 660 byMasimo Corporation, Irvine, Calif. The sensor 102 and the signalprocessing device 110 of the oximeter 660 are integrated into a singlepackage.

FIG. 6G illustrates a physiological parameter assembly 670 comprising asensor 102 applied to the toe and a signal processing device 110 in anankle band for discreetly monitoring for opioid overdose conditions.

FIG. 6H illustrates a monitoring hub 680 comprising a ROOT® monitoringhub 326 with a Radical-7® pulse oximeter 200, both by MasimoCorporation, Irvine, Calif. The medical monitoring hub 680 can expandmonitoring capabilities by bringing together signal processing anddisplay for multiple physiological parameters, such as brain functionmonitoring, regional oximetry, and capnography measurements.

FIG. 6I illustrates a physiological parameter assembly 690 comprising asensor 102 and a signal processing device 110 that can be worn as aglove. When the glove is placed on the user's hand, the sensor 102 canbe placed on one of the fingertips. The sensor 102 can be a disposablesensor. The sensor 102 can be built inside or outside the fingers of theglove. The sensor 102 can be integrated to the fingers of the glove. Thecable of the signal processing device 110 can be integrated to theglove. Advantageously, the glove is easy to wear, stays in place, andcan be easily removed when the user is not in need of opioid overdosemonitoring. The glove 690 can fasten at the wrist with a strap, hook andloop fastener, and the like. The sensor 110 can be wireless andcommunicates with the mobile device 120 using wireless technology, suchas Bluetooth®, and the like.

FIG. 6J illustrates a physiological parameter assembly 695 comprising asensor 102 and a cable for connection to a signal processing device. Thesensor 102 can be a disposable sensor. The sensor 102 can be placedaround a finger. The sensor 102 can communicate sensor data wirelessly.

Instrumentation-Mobile Computing Device

Any mobile computing device 120 that is compatible with thephysiological parameter assembly that includes the sensor 102 and thesignal processing device 110 can be used. A compatible mobile computingdevice can be one of a wide range of mobile devices such as, but notlimited to a mobile communications device (such as a smartphone),laptop, tablet computer, netbook, PDA, media player, mobile gameconsole, wristwatch, wearable computing device, or other microprocessorbased device configured to interface with the signal processing device110 and provide notifications based at least in part on the monitoredphysiological parameters 118.

Referring to FIG. 2A, the mobile computing device 120 can include adisplay 122 for display of the physiological parameters, for example ina user interface and/or software application, as discussed in moredetail below. The display 122 can include a display screen such as anLED or LCD screen, and can include touch sensitive technologies incombination with the display screen. Mobile computing device 120 caninclude software configured to display some or all of the outputmeasurement data on the display screen. The data display can includenumerical or graphical representations of blood oxygen saturation, heartrate, respiration rate, pleth variability, perfusion index, and/or arespiratory efforts index, and may simultaneously display numerical andgraphical data representations.

The mobile computing device 120 can include a user interface 126 thatcan receive user input. The user interface 126 can include buttons, akey pad, the touch sensitive technologies of the display screen 122, andother user input mechanisms typically found on the various examplemobile computing devices 120.

The mobile computing device 120 can also include data storage 124, whichcan be configured for storage of the physiological parameters 118 andparameter history data and/or software applications that monitor thephysiological parameters for an overdose indication and providenotifications. The storage 124 can be physical storage of the mobilecomputing device 120, and the storage 124 can be remote storage, such ason a server or servers of a data hosting service.

The mobile computing device 120 can also include a network connectivityfeature 128 that provides network connection capabilities such as one ormore of a cellular network, satellite network, Bluetooth, ZigBee,wireless network connection such as Wi-Fi or the like, and a wirednetwork connection. The mobile computing device 120 can also include adata transfer port.

Application Functionality Overview

The mobile computing device 120 can include software such as anapplication 130 configured to manage the physiological parameters 118from the physiological parameter monitoring device 110. The applicationfunctionality can include trend analysis, current measurementinformation, alarms associated with above/below threshold readings,reminders to take measurement data at certain times or cycles, displaycustomization, iconic data such as hearts beating, color coordination,bar graphs, gas bars, charts, graphs, or the like, all usable by acaregiver or application user to provide medical monitoring of specifiedphysiological parameters. The display 122 can display the physiologicalparameters 118 as numerical values, graphs, charts, dials and the like.

The application 130 via the mobile computing device 120 can also alertthe user and/or person(s) designated by the user to an abnormal datareading. For example, an abnormally low blood oxygen saturation readingcan cause the mobile computing device 120 to buzz, vibrate or otherwisenotify the user of an abnormal reading, and to transmit a notificationor alert to the user, the designated person(s) or medical personnel to anetwork via the network connectivity 128.

In addition, the application 130 includes one or more processes tomonitor the physiological parameters 118 for the condition of the user,and in particular for signs of an opioid overdose. The application 130can be set up by the user or a caregiver to notify another of theoverdose event. This increases the likelihood that the opioid user,their immediate personal networks, and first responders are able toidentify and react to an overdose by administrating medication used toreverse the effects of an opioid overdose, such as naloxone. Naloxone isan overdose-reversal drug. In some states, people who are or who knowsomeone at risk for opioid overdose can go to a pharmacy orcommunity-based program to get trained on naloxone administration andreceive naloxone by “standing order,” which means a patient-specificprescription is not required. When administered in time, naloxone canrestore an overdose victim's breathing long enough for trained medicalassistance to arrive. In some instances, other overdose reversal drugscan be used, such as buprenorphine, and combination of buprenorphine andnaloxone, and the like.

The application 130 can include processes and information to monitor andprovide care to opioid users, such as, but not limited to an overdosedetection process 131 configured to determine the condition of the userand whether medical care is indicated based at least on thephysiological parameters 118, an alert management process 132 configuredto manage alerts to the user and others in the user's network based atleast in part on condition of the user, and information for thecare/treatment for opioid use, such as a critical care instruction video133.

Opioid Overdose Monitoring

FIG. 2B illustrates an example process 200 to monitor physiologicalparameters 118 for opioid use and provide notifications. At block 205,the sensor 102 collects the raw data 104 from the user. In the case of apulse oximeter sensor, the sensor 102 passes light, such as red andinfrared light through a body part to a photodetector. The raw data 104from the sensor 102 provides respiration information due to theabsorbance of the light in the pulsating arterial blood.

At block 210, the signal processing device 110 receives the raw data 104from the sensor 102, processes the raw data 104 to provide one or moreparameters 118 to the mobile computing device 120. In the case of pulseoximetry, the signal processing device 110 generates a blood-volumeplethysmograph waveform from which at least the peripheral oxygensaturation of arterial blood (SpO₂), respiration, pulse rate, andperfusion index (PI) may be determined. Other physiological parametersthat may be determined are, for example, oxygen content (SpOC), bloodglucose, total hemoglobin (SbHb), methemoglobin (SbMet),carboxyhemoglobin (SpCO), bulk tissue property measurements, watercontent, pH, blood pressure, cardiac information, and pleth variabilityindices (PVI). Sensor data 104 can provide information regardingphysiological parameters 118 such as, for example, EEG, ECG, heart beatsper minute, acoustic respiration rate (RRa), breaths per minute,end-tidal carbon dioxide (EtCO₂), respiratory effort index, and returnof spontaneous circulation (ROSC).

User Input

At block 215, the application 130 via the mobile computing device 120can query the user and receive user input. The mobile computing device120 can present questions on the display 122 and the user can replyusing the user interface 126. For example, the user can be asked for theinformation on the prescription label, the dosage and/or frequency ofthe opioid being consumed and any other drugs the user is consuming. Themobile computing device 120 can ask the user to input his weight, age,and other physical attributes that may be factors in the user's reactionto the opioid and dosages of the medication, such as naloxone and thelike, used to reverse the effects of an overdose. The mobile computingdevice 120 can ask whether the user is OK or in need of assistance. Aresponse from the user can indicate that the user is conscious and notoverdosed. The application 130 can ask the user for a response when theanalysis of the parameters 118 indicates an overdose event, and if aresponse is received, indicating the user is conscious and notoverdosed, the application 130 can refine the threshold used todetermine an overdose event. The mobile computing device 120 can confirmthe users name and location.

Trends

At block 220, the application 130 can develop trends in the user'sopioid usage using the physiological parameters 118 from past monitoringstored in the storage 124 as well as user input relating to weight, age,dosage, frequency, and additional drugs being consumed. The trends canbe based on the parameters 118 and the user input, if any is received.

For example, opioid users that are also marijuana users can develop agreater tolerance for opioids. Further, opioids initially cause theperfusion index to increase due to vasodilation, then to decrease due tovasoconstriction. The increase and decrease of the perfusion indexcreates a perfusion profile. A user with a greater tolerance to opioidscan have a different perfusion profile than a user that does not usemarijuana in conjunction with opioids.

The application 130 can use the user input, if available, and storedphysiological parameters, such as the perfusion profile, for example,and current physiological parameters to develop trends in the user'sopioid usage and/or tolerance for opioids that can more accuratelyanticipate an overdose event. The application 130 can use pastoccurrences of “near misses” to further refine the conditions that mayforeshadow an overdose event. A “near miss” is an event that providedindications of an overdose, such as an indication of respiration below athreshold, but did not result in an overdose event. The opioid dosageassociated with a near miss can provide an indication of the user'stolerance to opioids and can be used by the application 130 to refinethe determination of an imminent or occurring opioid overdose event.

By using the history of the physiological parameters 118 including thenear-misses, and the user input, if available, the application 130 canlearn which combination of events and parameter values indicate anoverdose event may be imminent. Because time is of the essence inadministrating medication, such as naloxone and the like, to reverse orreduce the effects of an overdose to an overdose victim, it is desirableto err in over-reporting, but too many false-positives of opioidnotifications may desensitize responders. It is important that theapplication 130 learn the specific triggers for a specific user toincrease accuracy in determining an overdose event for the specificuser. The application 130 can learn the conditions leading up to anoverdose event and refine its algorithm in order to notify others whenhelp is needed and to discriminate against false-positive events.

The user's tolerance, as well as the user's physical attributes, such asweight and age, can be used by the application 130 to refine thequantity of medication that reverses or reduces the effects of anoverdose, such as naloxone and the like, that should be administered torevive the user in an overdose event. The application 130 can monitordoses of the medication and report the dosages to clinicians who candetermine whether the dosage is too high or too low.

The process 200 uses one or more of the user input, currentphysiological parameters, stored physiological parameters, “near miss”events, overdose events, to refine the indications of an overdose eventso as to be able to more accurately determine the occurrence of anoverdose event without notifying others of an overdose event that turnsout to be false. Because time is of the essence in responding to anoverdose victim, the application 130 may err on the side of overnotification, but can learn the triggers for the specific user to avoid“crying wolf”, which may result in others ignoring the notifications.

Data Analysis

At block 225, the application 130 determines the condition of the userbased on one or more of the physiological parameters, user input, andtrends. For example, the application 130 can compare the physiologicalparameters 118 against a threshold to determine is an overdose event isoccurring or will soon occur. For example, opioids depress the user'sbreathing. If the one or more of the oxygen saturation, breaths perminute, perfusion index and respiratory effort index indicaterespiratory failure but being less that a threshold, the application maydetermine that an overdose event has occurred. The threshold can be apredetermined threshold that is adjusted as the application 130 learnsthe overdose triggers associated with the user. As the application 130develops the trends, the application can refine the thresholds for oneor more of the physiological parameters 118.

The application 130 can use the user's perfusion index to determine thelikelihood of an overdose event. For example, opioids initially causethe perfusion index to increase due to vasodilation, then to decreasedue to vasoconstriction. This can be an identifiable perfusion profilethat anticipates an overdose event.

The application 130 can use one or more physiological parameters 118 todetermine the condition of the user. The application 130 can use one ormore of the perfusion index (PI), respiration, and peripheral oxygensaturation (SpO₂) to determine the condition of the user. For example,the application 130 can use, but is not limited to, each of theperfusion index (PI), respiration, and peripheral oxygen saturation(SpO₂) alone; a combination of the PI, respiration, and SpO₂ together; acombination of PI and respiration; a combination of PI and SpO₂; or acombination of respiration and SpO₂ to determine the condition of theuser. The analysis of the physiological parameters 118 may show that thephysiological parameters are within normal ranges and the user is not inneed of assistance or the analysis may indicate that an overdose eventis imminent, is occurring, or has occurred.

Other physiological parameters 118 can be analyzed individually or inother combinations can be analyzed to determine whether thephysiological parameters 118 of the user are within normal ranges orwhether an overdose event is imminent, is occurring, or has occurred.

The application 130 can query the user to determine the condition of theuser. No response from the user can indicate that the user isunconscious and can trigger an overdose event notification or alarm. Asindicated above, a response from the user can indicate that the user isconscious and the information can be used by the application 130 torefine the changes in the user's physiological parameters 118 thatindicate an opioid overdose is occurring or will occur soon.

As described above, the mobile computing device 120 can include anaccelerometer that can detect user motion. A lack of user motion sensedby the accelerometer can indicate that the user in unconscious and cantrigger an overdose event notification or alarm. Motion sensed by theaccelerometer can indicate that the user is conscious and theinformation can be used by the application 130 to refine the changes inthe user's physiological parameters 118 that indicate an opioid overdoseis occurring or will occur soon.

As described above, the mobile computing device 120 can include anaccelerometer that can sense vibrations from the user indicative of theuser's heart rate. A lack of vibrations sensed by the accelerometer canindicate no heart rate and reduced occurrences of vibrations sensed bythe accelerometer can indicate cardiac distress, which can trigger anoverdose event notification or alarm. Heart rate within normalparameters can indicate that the user is not in need of assistance dueto an overdose event.

At block 230, the application 130 can determine whether care is usefulbased on the condition of the user. If care is indicated, such that thephysiological parameters indicate depressed respiration, but not at alife-threatening level, the application moves to block 235. At block235, the application 130 queries the user. If a response is received,the process 200 moves to the END block. A response indicates that theuser is conscious and not in need if immediate aid.

If, at block 230, the application 130 determines that care is requiredbecause the evaluation of the physiological parameters 118 indicate alife-threatening condition, the process 200 moves to block 240. Inaddition, if no response is received from the user query at block 235,the process 200 moves to block 240.

Notifications

At block 240, the application 130 provides notifications based at leastin part of the condition of the user. For example, the application 130can display on the display 122 the user's physiological parameters, suchas one or more of oxygen saturation, heart beats per minute,breaths-per-minute, pleth variability, perfusion index, and respiratoryeffort. The physiological parameters 118 can be displayed as charts,graphs, bar charts, numerical values, and the like. The application 130can display trends in the physiological parameters 118.

The application 130 can provide notifications to selected friendsindicating that there are no overdose conditions. The “everything is OK”notifications can be sent periodically or upon request. The “everythingis OK” notifications can be sent during known exposure times. Forexample, the “everything is OK” notifications can be sent every 30minutes from 6:00 PM when the user typically returns from work, to 11:00PM when the user typically goes to sleep.

The application 130 can also report “near misses” to the caregiver. Asdescribed above, a “near miss” is an event that provided indications ofan overdose, such as an indication of respiration below a threshold, butdid not result in an overdose event.

Once the application 130 has determined that an overdose condition isimminent, is occurring, or has occurred, the application 130 can providenotification of the overdose to selected family, friends, caregivers,clinicians, and medical personnel. The notification can be sent to acrowd sourced community of users, friends, and medical personnel thatlook out for one another. The application 130 can provide the locationof the user and/or directions to the user's location. The notificationcan include the location of the closest medical care and/or the locationof the closest medication that reduces or reverses the effects of anoverdose. Examples of such medications are, but not limited to,naloxone, buprenorphine, a combination of naloxone and buprenorphine,Narcan®, Suboxone®, Subutex®, and the like. The application 130 canindicate whether the overdose victim is conscious or unconscious.

The notification can include protocol for a first responder to renderaid to the user. The application 130 can provide the user data to themedical personnel to aid them in administrating the correct dose ofmedication that reduces or reverses the effects of an overdose, such asnaloxone and the like to the user. For example, if the overdose victimis also a heroin or marijuana user, the overdose victim may need alarger dosage of naloxone to reverse the effects of the opioid overdosethan an overdose victim that does not also use heroin or marijuana.Further, the naloxone dosage may also need to be adjusted for the weightand age of the overdose victim. For example, a greater dosage onnaloxone may be needed to reverse the depressed respiration effects ofopioid overdose for an adult than is needed for a small child.

The application can provide trend data to medical personnel or todesignated caregivers on a continual basis or may provide the trend datawith the overdose notification. The dosage of medication to reduce orreverse the effects of the overdose, such as naloxone and the like, canbe adjusted based at least in part on the trend data.

The application 130 can notify the user and request an acknowledgementfor the user. For example, the application 130 can provide a visualnotification on the display 122, and then cause the mobile computingdevice 120 to provide an audible notification, such as an audible alarmwhich can escalate to an increasing louder piercing sound in an attemptto wake up the user. The audible notification can include the name ofthe user. The application 130 can interact with a home system, such asAlexa®, Amazon Echo®, and the like, to create the alarm. The application130 can cause the mobile computing device 120 or the home system, forexample, to contact a live person who can provide immediate careinstructions to the first responder.

The application 130 can provide the notifications to others in theuser's community that have downloaded the application 130 on theirmobile computing device. The application 130 can cause the mobilecomputing device 120 to send, for example, but not limited to textmessages, emails, and phone calls to selected contacts in the user'smobile device 120, who may or may not have downloaded the application130 to their mobile computing device 120. The mobile computing device120 can automatically dial 911 or other emergency response numbers. Theapplication 130 can transmit the location of the user to one or moreselected ambulances and paramedics.

FIGS. 3A-3E illustrate various example software applications to provideinformation, notifications, and alerts to opioid users, firstresponders, medical personnel, and friends.

FIG. 3A is a screenshot 300 illustrating a request for user input. Theillustrated screenshot 300 displays a question “ARE YOU OK? DO YOU NEEDMEDICAL ASSISTANCE?” and selections for the user's response. If noresponse is received, the user may be assumed to be unconscious. If aresponse is received, the application 130 can use the physiologicalparameters 118 associated with the response to refine the algorithm todetermine an overdose event for the specific user. The refinements caninclude refinements to the overdose threshold for the physiologicalparameters 118 or can include refinements to the parameter trendsassociated with an overdose event.

FIG. 3B is a screenshot 310 illustrating a periodic status alert thatcan be send via text message or email to friends or family that have setup periodic well checks for the user in the user's application 130. Theillustrated screenshot 310 also indicates when the next well check willoccur.

FIG. 3C is a screenshot 320 illustrating a status alert that can be sendvia text message or email to friends or family that have set up periodicwell checks for the user in the user's application 130. The illustratedscreenshot 320 indicates current values for monitored physiologicalparameters and provides a section SEE TRENDS to view the trend data forthe physiological parameters. The illustrated screenshot 320 alsoindicates the date and time of the most recent overdose event.

FIG. 3D is a screenshot 330 illustrating first responder protocols. Theillustrated screenshot 330 displays resuscitation information for theperson(s) responding to the overdose notification.

FIG. 3E a screenshot 340 illustrating the nearest location to the userthat has available naloxone. The illustrated screenshot 340 displays anaddress and a map of the location.

Notify a Friend

FIG. 4 illustrates an example process 400 to monitor for opioid overdoseusing the mobile physiological parameter monitoring system 100 includingthe sensor 102 and the signal processing device 110, and the mobilecomputing device 120. The user or the caregiver downloads theapplication 130 into the mobile computing device 120. The user orcaregiver can select a person or persons to be notified by the mobilecomputing device 120 when the application 130 determines an opioidoverdose event is occurring. The mobile computing device 120 cancomprise a mobile communication device, such as a smartphone. The userattaches the sensor 102 to a body part, such as clipping the sensor 102onto a finger, a toe, the forehead, for example, and connects eitherwirelessly or via a cable to the mobile computing device 120 thatincludes the application 130.

At block 405, the mobile physiological parameter monitoring system 100collects raw data 104 from the sensor 102. At block 410, signalprocessing device 110 processes the raw data and provides the mobilecomputing device 120 with physiological parameters 118.

At block 415, the mobile computing device 120 receives the physiologicalparameters 118 from the physiological parameter monitoring device 110.

At block 420, the application 130 displays on the display 122 of themobile computing device 120 the physiological parameters 118. The mobilecomputing device 120 can display numerical indications, graphs, piecharts, dials, and the like. The displays can include acceptable andunacceptable ranges for the physiological parameters 118. The displaycan be color coded. For example, acceptable ranges can be colored greenand unacceptable ranges can be colored red. The application 130 candisplay on the mobile computing device 120 the physiological parameters118 as the physiological parameters 118 are received (in real time) orat approximately the same time (near real time) as the physiologicalparameters 118 are received.

At block 425, the application 130 can monitor the physiologicalparameters 118 for indications of an opioid overdose. The monitoredphysiological parameters 118 can include the physiological parametersthat are most likely affected by an overdose condition. Thephysiological parameters 118 can be one or more of the oxygensaturation, heart rate, respiration rate, pleth variability, perfusionindex, and the like of the user.

The application 130 can determine whether the physiological parameters118 indicate that the user needs on-site care. A blood oxygen saturationlevel below a threshold can indicate an opioid overdose condition. Forexample, the application 130 can monitor the oxygen saturation of theuser and trigger an alarm when the oxygen saturation falls below athreshold. The application 130 can compare the user's current oxygensaturation level with a threshold that can indicate a minimum acceptableblood oxygen saturation level. An oxygen saturation level below theminimum acceptable blood oxygen saturation level can be an indication ofan overdose event. For example, an oxygen saturation level belowapproximately 88 can indicate respiratory distress.

The application 130 can compare each of the monitored physiologicalparameters 118 with a threshold that indicates a minimum or maximumacceptable level for the physiological parameter 118. For example, theapplication 130 can compare the user's heart rate in beats per minutewith the acceptable range of approximately 50 beats per minute toapproximately 195 beats per minute. The application 130 can compare theuser's respiration rate in breaths per minute with the acceptable rangeof approximately 6 breaths per minute to approximately 30 breaths perminute. The application 130 can compare the user's pleth the acceptablerange of approximately 5 to approximately 40 and the user's perfusionindex to a minimum acceptable perfusion index of approximately 0.3.

One or more physiological parameters 118 can be weighted and when thecombination of weighted parameters falls below a threshold, theapplication 130 can trigger the notification of an opioid overdoseevent. One or more physiological parameters 118 can be weighted based ontrends in the user's physiological parameters during opioid use and whenthe combination of weighted parameters falls below a threshold, theapplication 130 can trigger the notification of an opioid overdoseevent.

When the measured physiological parameters 118 are within acceptableranges, the process 400 can return to block 415 and the mobile computingdevice 120 can continue to receive the physiological parameters 118 fromthe sensor 102 via the physiological parameter monitoring device 110.The application 130 can compare one, more than one, or all of themeasured physiological parameters 118 to determine an overdose event.

When an overdose is indicated as imminent or occurring, the process 400moves to block 430. For example, when the user's blood oxygen saturationlevel is at or below the threshold, the application 130 triggers analarm at block 430. When at least one of the monitored parameters 118 isbelow an acceptable threshold, the process 400 can trigger an alarm. Thealarm can be an audible alarm that increases in loudness, frequency, orpitch. The alarm can be the user's name, a vibration, or a combinationof audible sound, vibration, and name.

The mobile computing device 120 can vibrate, audibly alarm, display awarning, visibly flash, and the like to notify the user or someone atthe same physical location as the mobile computing device 120 to theoverdose event. The alarm can be an audible alarm that increases inloudness, frequency, or pitch. The alarm can be the user's name, avibration, or a combination of audible sound, vibration, and name.

The mobile computing device 120 can display the location of and/ordirection to naloxone or other medication to reverse or reduce theeffects of an overdose closest to the user. The mobile computing device120 can display the phone number of the person associated with theclosest medication to reverse or reduce the effects of an overdose, suchas naloxone. The mobile computing device 120 can display resuscitationinstructions to the first responder. The mobile computing device 120 canrequest an acknowledgement from the first responder. The mobilecomputing device 120 can display the resuscitation instructions to thefirst responder, call medical personnel, and facilitate questions andanswers between the first responder and the medical personnel.

If the user is alone, this may not be enough to avoid a life-threateningoverdose condition. At block 435, the application 130 can send anotification to the user's network, such as the person(s), emergencypersonnel, friends, family, caregivers, doctors, hospitals selected tobe notified. The notification can be sent in conjunction with thenetwork connectivity 128 of the user's mobile computing device 120. Thenotification informs the selected person(s) of the user's opioidoverdose. For example, the selected person(s) can receive a notificationon their mobile computing device. The selected person(s) can be afriend, a group of friends, first responders, medical personnel, and thelike. The mobile computing device 120 can automatically dial 911 orother emergency response numbers.

The notification can be sent to a crowd sourced community of opioidusers that look out for one another, such as a community of individualsand/or organizations associated with one or more opioid users. Thecommunity functions to provide help to opioid users and can includes notonly other opioid users, but friends, family, sponsors, firstresponders, medics, clinicians, and anyone with access to medication toreverse or reduce the effects of an overdose, such as naloxone.

The notification can be one or more of text message, an automaticallydialed phone call, an email, or the like. The notification can includeone or more of a graphical representation, a numerical value or the likeof the user's unacceptable or out-of-acceptable-range physiologicalparameter 118, the time of the overdose, the location of the user,directions to the location, and the phone number of the user's mobilecomputing device 120. The notification can also provide the location ofand/or direction to medication to reverse or reduce the effects of anoverdose, such as naloxone, closest to the user, as well as the phonenumber of the person associated with the closest medication to reverseor reduce the effects of an overdose, such as naloxone.

FIGS. 5A-5F illustrate various example software applications to triggeran alarm and notify a friend when an opioid overdoes is indicated.

FIG. 5A is an example screenshot 510 illustrating active monitoring ofphysiological parameters 118. The illustrated monitoring screenshot 510displays the user's oxygen saturation, heart rate as beats per minute,respiration rate as breaths per minute, pleth variability and perfusionindex. The physiological parameters 118 are represented as dials. Thedials indicate a normal range and unacceptable ranges that can be above,below or both above and below the normal range. A needle within the dialpoints to the current value of the physiological parameter and anumerical indication of the current value is displayed in the center ofthe dial.

FIG. 5B is an example screenshot 520 illustrating a home screen with themain menu. The illustrated home screen 520 includes a selection LIVE todisplay physiological parameters being monitored in real time or nearreal time, such as shown on the monitoring screenshot 510. The homescreen 520 further includes a selection for HISTORY, HEART RATERECOVERY, and NOTIFY A FRIEND.

Selecting HISTORY can display the past physiological parameters storedin storage 124 as one or more of graphs, charts, bar graphs, and thelike. The application 130 can use the HISTORY to develop trends for thespecific opioid user to more accurately determine when an opioidoverdose event is imminent.

Heart rate is the speed of the heartbeat measured by the number ofcontractions of the heart per minute (bpm). The heart rate can varyaccording to the body's physical needs, including the need to absorboxygen and excrete carbon dioxide. Selecting HEART RATE RECOVERY candisplay the recovery heart rate of the user after a near opioid overdoseor overdose event.

Selecting NOTIFY A FRIEND allows the user or a caregiver to select acontact from the mobile computing device 120 to be notified in the eventthat the user's physiological parameters 118 indicate that the user isexperiencing or will soon experience an overdose event.

The home screen 530 further includes a setup section that includesDEVICE, SOUND, DATA, MEASUREMENT SETTINGS, APP INTEGRATION, ABOUT, ANDSUPPORT. The user can receive information, such as device data, forexample, or select setting, such as what measurements are displayed,change alarm volume, and the like.

FIG. 5C is an example screenshot 530 illustrating the NOTIFY A FRIENDscreen. The illustrated NOTIFY A FRIEND screen 530 allows the user orcaregiver to select a person from the contacts stored on the mobilecomputing device 120 to be contacted when an overdose event occurs. Inthe illustrated NOTIFY A FRIEND screen 530, the second person on thecontact list has been selected.

FIG. 5D is an example screenshot 540 illustrating live or activemonitoring of the user having an alarm condition. The illustratedparameter monitoring screen 540 shows that the user's oxygen saturationlevel has dropped below an acceptable threshold of 88 to a value of 73.This indicates an overdose event may be occurring. The user's heartrate, respiration rate, pleth variability and perfusion index have notchanged from the values displayed on the live monitoring screen 510.

FIG. 5D also includes a RESPIRATORY EFFORT INDEX, which provide anindication of whether breathing is occurring or is suppressed.

FIG. 5E is an example screenshot 550 illustrating a notification screensent to the friend/selected contact to notify the friend of the user'soverdose event. Once the alarm is triggered on the user's mobilecomputing device 120, the selected person is notified of the alarmstatus. The notification screen 550 can display the user's name and thealarm condition. The illustrated notification screen 550 informs thefriend that Ellie Taylor has low oxygen saturation of 73. Selecting ortouching the VIEW selection provides additional information.

FIG. 5F is an example screenshot 560 illustrating the friend alertincluding additional information provided to the selected person. Thefriend alert screen 560 can include the trend and current value of thealarming parameter. For example, the illustrated friend alert screen 560displays the graph and current value of the user's oxygen saturation.The friend alert screen 560 can also display the user's location on amap, display the time of the initial alarm event, provide access todirections to the user from the friend's current location in one touch,and provide access to call the user in one touch. The friend has theknowledge that the user is overdosing and the information to providehelp.

Assistance for Responders and Caregivers

It is critical to administer an opioid receptor antagonist, such asNaloxone, to victims of opioid overdoses as soon as possible. Often itcan be a matter of life or death for the overdose victim. As describedherein, self-administrating delivery devices can administer the opioidreceptor antagonist without user or responder action. Opioid overdosevictims without a self-administrating delivery device rely on theresponders, friends, or caregivers that are first on the scene toadminister the opioid receptor antagonist. Assistance that can beprovided to the first responders can be useful and the assistance cantake many forms. The assistance can be visual or auditory indicatorsand/or instructions. The user can wear a band, such as a wrist band, forexample, that changes color to indicate an opioid overdose event. Adisplay, such as a display on a mobile device, can change color, orflash to draw attention when an opioid overdose event is detected. Themobile or other device can transmit a notification or transmit theflashing display to other devices within range to notify others of theopioid overdose event. The display can display instructions that explainhow to administer the opioid receptor antagonist, such as Naloxone. Thedisplay can display instructions to wake the overdose victim usingsmelling salts, shaking, escalation of painful stimulation, loud noises,or any combination of these. The responder can be instructed toincrementally increase aggressive actions to wake the overdose victim.An example of incrementally increasing aggressive action can be loudsound, followed by a small amount of painful stimulation, followed byadministration of a small amount of Naloxone or other opioid receptorantagonist, followed by an increased amount of painful stimulation. Thefirst responder can be instructed to induce pain using acupuncture. Themobile or other device can speak the instructions to get the attentionof others that are nearby. The mobile or other device can speak “Pleaseinject Naloxone” to indicate urgency. The mobile or other device canbeep to attract attention. The mobile or other device can buzz and/orprovide voice directions to help in directionally finding the overdosevictim.

The mobile or other device can provide codes to emergency personnelwithin proximity. The mobile or other device can send a signal toemergency personnel or police indicating that the Naloxone needs to bedelivered as soon as possible.

The first responder can also administer medication to induce vomitingonce the overdose victim is awake and upright. The user may regurgitateany opioid substances, such as pills, for example, that are still in theuser's stomach.

Network Environment

FIG. 7A illustrates an example network environment 700 in which aplurality of opioid user systems 706, shown as opioid user systems 706A. . . 706N, communicate with a cloud environment 702 via network 704.The components of the opioid user systems 706 are described in greaterdetail with respect to FIG. 7C.

The network 704 may be any wired network, wireless network, orcombination thereof. In addition, the network 704 may be a personal areanetwork, local area network, wide area network, over-the-air broadcastnetwork (e.g., for radio or television), cable network, satellitenetwork, cellular telephone network, or combination thereof. Forexample, the network 704 may be a publicly accessible network of linkednetworks such as the Internet. Protocols and components forcommunicating via the Internet or any of the other aforementioned typesof communication networks are well known to those skilled in the artand, thus, are not described in more detail herein.

For example, the opioid user systems 706A . . . 706N and the cloudenvironment 702 may each be implemented on one or more wired and/orwireless private networks, and the network 704 may be a public network(e.g., the Internet) via which the opioid user systems 706A . . . 706Nand the cloud environment 702 communicate with each other. The cloudenvironment 702 may be a cloud-based platform configured to communicatewith multiple opioid user systems 706A . . . 706N. The cloud environment702 may include a collection of services, which are delivered via thenetwork 704 as web services. The components of the cloud environment 702are described in greater detail below with reference to FIG. 7B.

FIG. 7B illustrates an example of an architecture of an illustrativeserver for opioid user monitoring. The general architecture of the cloudenvironment 702 depicted in FIG. 7B includes an arrangement of computerhardware and software components that may be used to implement examplesof the present disclosure. As illustrated the cloud environment 702includes one or more hardware processors 708, a remote applicationmanager 710, a registration manager 712, a map server manager 714, adistress notification manager 716, a non-distress manager 718, and anopioid user database 720, all of which may communicate with one anotherby way of a communication bus. Components of the cloud environment 702may be physical hardware components or implemented in a virtualizedenvironment. The remote application manager 710, the registrationmanager 712, the map server manager 714, the distress notificationmanager 716, and the non-distress 718 manager may include computerinstructions that the one or more hardware processors execute in orderto implement one or more example processes. The cloud environment 702may include more or fewer components than those shown in FIG. 7B.

The remote application manager 710 may oversee the monitoring andnotifications of associated with the plurality of opioid user systems706A . . . 706N. The remote application manager 710 is remote in thesense that it is located in a centralized environment as opposed to eachopioid user's local environment. The remote application manager 710 mayoversee the registration manager 712, the map server manager 714, thedistress notification manager 716, and the non-distress notificationmanager 718. The remote application manager 710 may perform one or moreof the steps of FIGS. 2B, 4.

The registration manager 712 may manage the information associated witheach opioid user registrant and the contact information supplied by eachopioid user registrant during registration for the opioid overdosemonitoring system. The contact information may include the names, phonenumber, email addresses, etc. of individuals and/or organizations tocontact on behalf of the opioid user when an overdose event is predictedor detected, or for status check information, as well as the name,address, phone number, email address, etc. of the opioid userregistrant. Examples of individuals and organizations are illustrated inFIG. 1B. The opioid user information and the contact informationassociated with each opioid user registrant may be stored in database720. FIGS. 5B, 5C illustrate examples of interface screens that may beused during registration.

The map server manager 714 may locate maps and directions, such as thoseillustrated in FIGS. 3E and 5F to display on devices associated withfirst responders, friend and family, and other individuals from theopioid user's contact information to display maps or directions to theopioid user, to the location of the closest naloxone or other suchmedication to the opioid user, and the like, in the event of anoverdose. FIGS. 5E, 5F illustrate examples of distress notifications.The map server manager 714 may interface with third party map sites viathe network 704 to provide the maps and directions.

The distress notification manager may receive an alert from the opioiduser's mobile device that an overdose event may soon occur or hasoccurred. For example, the mobile device 120 or the monitoring device110 may process the sensor data from the sensors 102 and determine thatan overdose event is occurring. The mobile device 120 may communicationthe occurrence of overdose event with the distress notification manager716. The distress notification manager 716 may retrieve contactinformation from the database 720 and provide notification of theoverdose event or a soon to occur overdose event to the individuals andorganizations indicated by the opioid user during registration so thatassistance can be provided to the opioid user. FIG. 5F illustrates anexample of a distress notification.

The non-distress notification manager 714 may receive the status of theopioid user as monitored by the mobile device 120 and/or the monitoringdevice 110. The non-distress notification manager 718 may receive thestatus periodically. After determining that the status of the opioiduser indicates that the opioid user is not in distress, the non-distressnotification manager may access the database 720 to retrieve the contactinformation for the individual and organizations that are to be notifiedof the well-being of the opioid user. FIGS. 3B, 3C, 5D illustrateexamples of non-distress notifications.

FIG. 7C illustrates an example opioid user system 706, which includesthe monitoring device 740 and the mobile communication device 722. Themonitoring device can include the sensor(s) 120 that are sensingphysiological state of the opioid user and the signal processing device110 that is processing the raw sensor data from the sensor(s) 110 toprovide the mobile communication device 722 with the physiologicalparameters 118. The raw sensor data 104 from the sensor(s) 102 can beinput into the mobile communication device 722, which processes the rawsensor data 104 to provide the physiological parameters 118 of theopioid user.

The illustrated mobile communication device 722 includes a display 724,similar to display 122, described herein, a network interface 726 thatis configured to communication at least with the cloud environment 702via the network 704, a local application 728, a monitoring application730, a distress application 732, a non-distress application 734, a queryopioid user application 736, and a local alarm application 738. Thelocal application 728, the monitoring application 730, the distressapplication 732, the non-distress application 734, the query opioid userapplication 736, and the local alarm application 738 may be softwareinstructions stored in memory within the mobile communication device 722that are executed by the computing devices within the mobilecommunication device 722. The applications 728-738 can be downloadedonto the mobile communication device 722 from a third party or from thecloud environment 702. The mobile communication device 722 may includemore or fewer components than those illustrated in FIG. 7C.

The local application 728 may oversee the communication with the remotemonitoring manager of the cloud environment and may oversee themonitoring application 730, the distress application 732, thenon-distress application 734, the query opioid user application 736, andthe local alarm application 738. The local application 728 is local inthe sense that it as well as its associated applications 730-738, arelocated on the mobile communication device 722 associated with theopioid user, devices associated with organizations to assist opioidusers, and devices associated with individuals that are associated withthe opioid user.

The monitoring application 730 may receive the physiological parameters118 and process the physiological parameters according to one or more ofthe steps of FIGS. 2B, 4. The monitoring application 730 may cause thedisplay of the physiological parameters 118 on the display 724 mobilecommunication device 722. FIGS. 5A, 5D illustrate examples of displaysof the physiological parameters.

The distress application 732 may be called when the monitoringapplication 730 determines that the opioid user is experiencing anoverdose event or an overdose event is imminent. The distressapplication 732 may perform one or more steps of FIGS. 2B, 4, such assend out distress notifications. Further, the distress application 732may communicate with the distress notification manager 716 in the cloudenvironment 702 to cause the distress notification manager to providedistress notifications as described above.

The non-distress application 734 may be called when the monitoringapplication 730 determines that the opioid user is not experiencing anoverdose event or an overdose event is not imminent. The non-distressapplication 734 may perform one or more steps of FIGS. 2B, 4, such assend status notifications. Further, the non-distress application 734 maycommunicate with the non-distress notification manager 718 in the cloudenvironment 702 to cause the non-distress notification manager toprovide status notifications as described above.

The query opioid user application 736 may be called when the monitoringapplication 730 determines that care is indicated. The query opioid userapplication 736 queries the user to determine whether the user isconscious in order to reduce false alarms. The query opioid userapplication 736 may perform step 235 of FIG. 2B. FIG. 3A illustrates adisplay to query the user that may be caused by the query opioid userapplication 736.

The local alarm application 738 may be called when the monitoringapplication 730 determines that on-site care of the opioid user isrequired. The local alarm application 738 may perform step 430 of FIG.4. The local alarm application 738 may cause the mobile communicationdevice 722 to display first responder instruction, a map or directionsto the nearest facility with medication to reverse or reduce the effectsof an overdose, such as naloxone, and the like. The local alarmapplication 738 may cause the mobile communication device 722 to audiblyalarm and/or visually alarm to alert anyone near the mobilecommunication device 722 of the overdose event. FIG. 3D illustrates anexample of a first responder instructions and FIG. 3E illustrates anexample of a display displaying the location of naloxone.

FIG. 8 is a flowchart of an example process 800 to notify an opioiduser's notification network of the status of the opioid user. Theprocess 800 can be performed by the cloud environment 702. At block 802,the cloud environment 702 receives a user identification and user statusfrom the opioid monitoring system 706. For example, the remoteapplication manager 710 retrieves the user information from the database720 based on the user identification.

At block 802, the cloud environment 702 may determine, based on thestatus of the user, whether care is indicated. The status informationmay comprise the physiological parameters 118 from the monitoringapplication 730. The status may be an indication of whether care isindicated or not indicated. Remote application manager 710 may analyzethe physiological parameters 118 to determine whether care is indicated.

If care is indicated at block 804, the process 800 moves to block 806.At block 806, the distress notification manager 716 may retrieve thecontact information stored in the database and associated with the useridentification.

At block 808, the distress notification manager 716 may notify theindividuals and organizations of the contact information of the need forcare.

If care is not indicated at block 804, the process 800 moves to block810. At block 810, the non-distress notification manager 718 mayretrieve the contact information stored in the database and associatedwith the user identification.

At block 812, the non-distress notification manager 718 may notify theindividuals and organizations of the contact information of the statusof the opioid user. The non-distress notification manager 718 can sendan “Everything OK” message.

Communication Between Opioid Overdose Monitoring Application andTransportation/Ride Sharing Services

A mobile device or other computing device executing the opioidmonitoring application can communicate with one or more transportationservices such as, a ride sharing service, such as Lyft® or Uber®, forexample, a taxi service, or any commercial transportation service, whenan overdose event is occurring or imminent. This is illustrated in FIG.1B as “Rideshare network” that is within the representation of thelocation of naloxone message. The opioid monitoring application maycommunicate, via the mobile computing device, with servers associatedwith the ridesharing services over a network such as the Internet. Thecommunication can be entered into the transportation service system thesame as a person would normally call for a taxi, Lyft, or Uber, forexample.

The transportation service can receive a notification from the mobiledevice or other computing device that is deploying the opioid overdosemonitoring application. The notification can be an alert. The alert maybe for an ongoing or an imminent opioid overdose event. The notificationmay include the address of the opioid user, the address of the nearestfacility with medication to reverse or reduce the effects of anoverdose, such as naloxone, buprenorphine, combination of buprenorphineand naloxone, and the like, and the address of the nearest caregiver,emergency service, treatment center, and other organizations orindividuals that can provide life-saving care to for the opioid user.

The transportation service can transport the opioid user to receivecare, transport the opioid user to a location having the medication,transport the medication to the opioid user, to pick up the medicationand transport the medication to the opioid user, and the like.

The transportation service or ride sharing service can bill for thetransportation that occurs after receiving an alert or notificationgenerated by the opioid overdose monitoring application as a specialbilling or a charitable billing. The transportation service or ridesharing service can bill for the transportation in the same manner thatits transportation services are billed for a typical customer.

The transportation service or ride sharing service can participate in acommunity outreach program to provide transportation responsive toreceiving an alert or notification generated by the opioid monitoringapplication.

Physiological Monitoring and Medication Administration System

Including Activation Circuitry

FIG. 9A is a block diagram of an example physiological monitoring andmedication administration system 900. The illustrated physiologicalmonitoring and medication administration system 900 is like thephysiological monitoring system 100 of FIG. 2A except that an applicator904 having medication to reverse or reduce the effects of an opioidoverdose, such as an opioid receptor antagonist, and at least signal 902from the mobile communication device 120 to actuate the applicator 904are included in the physiological monitoring and medicationadministration system 900.

The applicator 904 can be worn by the user in a manner that facilitatesthe application of the medication. For example, the applicator 904 canbe strapped to the user's wrist, as illustrated in FIG. 13, and themedication can be applied through the skin, intramuscularly, orintravenously. The applicator can be configured as a watch band, abracelet, a vest-like garment worn next to the user's skin, or the like.The applicator can be configured to apply the medication intranasally,sublingually, or other methods of application.

FIGS. 9B and 9C are schematic diagrams 940, 950 of exampleself-administrating medication applicators. FIG. 9B illustrates anapplicator 944 configured to apply topical medication to reverse orreduce the effects of an opioid overdose. The applicator 944 includes anactuator 946 and medication in gel form 946. The gel 946 may becontained in a pouch or container with frangible seals, for example. Theactuator 946 can receive the actuation signal 902 from the mobile device120 to initiate the actuation process. In the illustrated applicator,the actuation signal 902 is received via an antenna. The actuationsignal 902 can be in electrical communication with the applicator 944via one or more wires. Once the applicator 944 receives the actuationsignal 902, the actuator can actuate to dispense the gel 948 onto theskin or tissue of the user. For example, the actuator can include a gassquib, that when activated, creates a pressurized gas or fluid that isin fluid contact with the gel 948, via one or more conduits, forexample. The pressurized fluid forces the gel 948 to break frangibleseals next to the tissue, causing the gel 948 to be applied to thesurface of the tissue.

FIG. 9C illustrates an applicator 954 configured to inject medication toreverse or reduce the effects of an opioid overdose into the tissue ofthe user. The applicator 954 includes a vial or container of injectablemedication, an actuator, and a needle 960. The needle 960 can be amicroneedle. The actuator can receive the actuation signal from themobile communication device 120 to initiate the actuation process. Inthe illustrated applicator, the actuation signal 902 is received via anantenna. The actuation signal 902 can be in electrical communicationwith the applicator 944 via one or more wires. Once the applicator 944receives the actuation signal 902, the actuator 958 can actuate toforce, by using pressure as described above, for example, the injectablemedication 956 through the needle 960. The needle 960 can be configuredto inject the medication 956 into the tissue under the pressuregenerated by the actuator 958.

FIG. 10 is a flow diagram of an example process 1000 to monitor foropioid overdose and to apply medication to reverse the effects of anoverdose. The process 1000 is like the process 400 of FIG. 4 except thatthe process 1000 includes steps activate an applicator worn on the bodyof the user, such applicator 904, 944, 954, and the like, to apply themedication to revere or reduce the effects of an opioid overdose. Oncethe need for on-site care is determined at block 425, the process 1000moves to block 430 to trigger an alarm and also to block 1002. At block1002, the applicator 904, 944, 954 receives an actuation signal 902,which actuates the applicator 904, 944, 954. At block 1004, themedication is dispensed from the application 904, 944, 954, and appliedto the user. The medication can be applied topically, throughintramuscular injection, through intravenous injection, and the like, tothe user to reverse or reduce the effects of the opioid overdose.

FIGS. 11A-11C are schematic diagrams of an example needle-freeinjection, multi-dose, self-administrating medication applicator 1100.The applicator 1100 can be configured to inject, without a hypodermicneedle, one or more doses of medication to reverse or reduce the effectsof an opioid overdose into the tissue of the user. FIG. 11A illustratesa side view of the needle-free injection, multi-dose,self-administrating medication applicator 1100 comprising an adhesivelayer 1102 configured to adhere the applicator 1100 to the skin and aprotective or safety layer 1104 configured to inhibit inadvertentdispensing of the medication. Other safety mechanism, such as a latch orsafety catch can be used to prevent inadvertent dispensing of themedication. To prepare the applicator 1100 for use, the user orcaregiver removes the safety layer 1104 and adheres the applicator 1100to the opioid user's skin.

FIG. 11B illustrates a cut-away side view of the applicator 1100 furthercomprising one or more activation circuitry 1106, antenna 1114, plungeror other dispensing mechanism 1108, reservoir 1110, and drug deliverychannel 1112. The activation circuitry 1106 is configured receive anactivation signal via the antenna 1114 and activate a delivery mechanism1108 to dispense medication in the reservoir 1110 through the drugdelivery channel 1112 through the skin, intramuscularly orintravenously. The medication can be naloxone, an opioid receptorantagonist, or the like to reduce the effects of an opioid overdoseevent. The delivery mechanism 1108 can be a plunger propelled forward bya propellant such as a CO2 cartridge, gas squib, compressed air, and N2gas cartridge, a pump motor, spring, and the like. The drug deliverychannel 1112 can be a small bore tube that forces the medication throughthe adhesive 1102 and the skin as a high pressure spray like a jetspray. The applicator 1100 deposits the medication in the tissue underthe administration site.

FIG. 11C illustrates a top cut away view of an example of theneedle-free injection multi-dose self-administrating medicationapplicator 1100. The applicator 1100 further comprises multiple doses ofthe medication. In the illustrated example, the applicator comprises 1to N applications, where each application is administered by activationcircuitry activating a plunger or other dispensing mechanism to dispensethe medication in the reservoir through the drug delivery channel asdescribed above in FIG. 9B. Each activation circuitry 1106 can receivean activation signal via the antenna 1114, where each antenna 1114(1) to1114(N) can be tuned to receive a unique activation signal such thatonly one activation circuit activates. More than one of antenna 1114(1)to 1114(N) can be tuned to activate with the same signal to dispensemedication from more than one reservoir upon receipt of the activationsignal.

FIGS. 12A-12B are schematic diagrams of an example injection,multi-dose, self-administrating medication applicator 1200. Theapplicator 1200 is configured to inject, using a hypodermic needle, oneor more doses of medication to reverse or reduce the effects of anopioid overdose into the tissue of the user. FIG. 12A illustrates acut-away side view of the injection multi-dose self-administratingmedication applicator 1200 comprising an adhesive layer 1202 configuredto adhere the applicator 1200 to the skin, one or more activationcircuitry 1206, antenna 1214, plunger or other dispensing mechanism1208, reservoir 1210, and needle 1212, which is shown in the retractedstate. In the illustrated example, a safety layer configured to inhibitinadvertent dispensing of the medication has been peeled away and theapplicator 1200 is adhered to the skin of the user at the dispensingsite. Other safety mechanisms, such as a latch, safety catch, or capover the needle 1212 can be used to prevent inadvertent dispensing ofthe medication. To prepare the applicator 1200 for use, the user orcaregiver removes the safety layer and adheres the applicator 1200 tothe opioid user's skin. The needle 1212 can be a microneedle.

The activation circuitry 1206 is configured receive an activation signalvia the antenna 1214 and activate a delivery mechanism 1208 to dispensemedication in the reservoir 1210 through the needle 1212 through theskin, intramuscularly or intravenously. The medication can be naloxone,an opioid receptor antagonist, or the like to reduce the effects of anopioid overdose event. The delivery mechanism 1208 can be a plungerpropelled forward by a propellant such as a CO2 cartridge, gas squib,compressed air, and N2 gas cartridge, a pump motor, spring, and thelike. The pressure from the delivery mechanism 1208 pushes themedication through the needle and causes the needle 1212 to move forwardthrough the adhesive layer 1202 and into the skin, muscle, vein or thelike at the deliver site. The needle 1212 can be a hypodermic needle orany sharp configured to inject substances into the body. The applicator1200 deposits the medication in the tissue under the administrationsite.

FIG. 12B illustrates a top cut away view of an example of the injectionmulti-dose self-administrating medication applicator 1200. Theapplicator 1200 further comprises multiple doses of the medication. Inthe illustrated example, the applicator 1200 comprises 1 to Napplications, where each application is administered by activationcircuitry activating a plunger or other dispensing mechanism to dispensethe medication in the reservoir through the needle as described above inFIG. 9B. Each activation circuitry 1206 can receive an activation signalvia the antenna 1214, where each antenna 1214(1) to 1214(N) can be tunedto receive a unique activation signal such that only one activationcircuit activates. More than one of antenna 1214(1) to 1214(N) can betuned to activate with the same signal to dispense medication from morethan one reservoir upon receipt of the activation signal.

FIG. 14 is a block diagram of example activation circuitry 1400 formulti-dose, self-administrating medication applicators, such asapplicators 1100 and 1200. The illustrated activation circuitry 1400comprises one or more antenna 1414, processing circuitry 1402, and aplurality of delivery circuitry and mechanisms 1410. A battery 1412 canbe used to power the activation circuitry 1400.

The applicator 1100 can further comprise an opioid overdose detectionsensor 1406, which can be considered a local opioid overdose detectionsensor because it is local to the user. The local opioid overdosedetection sensor 1406 can receive sensor data from the opioid user.Local opioid overdose detection sensor 1406 sends the sensor data to theprocessing circuitry 1402. The processing circuitry 1402 receives thesensor data from the local opioid overdose detection sensor 1406,processes the sensor data, and determines whether an opioid overdoseevent is occurring or will soon be occurring. The local opioid overdosedetection sensor 1406 can send the sensor data to the transceiver 1404.The transceiver 1404 sends the sensor data via the one or more antenna1414 to at least one of the mobile device 120, the server, and the hubfor processing. Once the data is processed, the transceiver 1404 canreceive via one or more antenna 1414 a signal indicating that the opioidoverdose event is occurring or soon will be occurring. The transceiver1404 sends the processing circuitry 1402 an indication that the opioidoverdose event is occurring or soon will be occurring.

The applicator 1100, 1200 may not include an opioid overdose detectionsensor 1408, such that the opioid overdose detection sensor 1408 can beconsidered remote from the applicator 1100, 1200. The remote opioiddetection sensor 1408 can send the sensor data to at least one of themobile device 120, the server, and the hub and when the processed sensordata indicates that an opioid overdose event is occurring, thetransceiver 1404 receives via one or more antenna 1414 a signalindicating that an opioid overdose event is occurring or soon will beoccurring. The transceiver 1404 sends the processing circuitry 1402 anindication that the opioid overdose event is occurring or soon will beoccurring. The remote opioid detection sensor 1408 can send sensor datawirelessly or through a wired connection to the processing circuitry1402.

The processing circuitry 1402 can determine that the opioid overdoseevent is occurring or will soon occur by processing the sensor data fromthe local opioid overdose detector sensor 1406 or can receive anindication from the transceiver 1404 that the opioid overdose event isoccurring or will soon occur. The processor 1402 can generate one ormore activate signals ACTIVATE(1) to ACTIVATE(N) to the delivery systemsDELIVERY(1) to DELIVERY(N), respectively, to dispense one or up to Ndoses of the medication. For example, if the physiology of the user issuch that a single dose of medication is insufficient, the processingcircuitry 1402 may be programmed to deliver multiple doses atapproximately the same time.

The processing circuitry 1402 can generate more than one activate signalat approximately the same time to deliver more than one dose of themedication to the user at approximately the same time. The processingcircuit 1402 can generate successive activate signals in response tosuccessive indications of an overdose event. For example, if theapplication of a first dose of medication does not reverse the effectsof an opioid overdose, the processing circuitry 1402 can generate asecond activation signal to provide a second dose of medication to theuser. The activation circuitry 1400 can count the number of dosesdispensed and provides an alert when the applicators 1100, 1200 areempty.

FIG. 15 is a flow diagram of an example process 1500 to administermedication from a self-administrating medication applicator 1100, 1200.At step 1415, the activation circuitry 1400 receives an indication thatan opioid overdose event is occurring or soon will be occurring. At step1420, the processing circuitry 1402 transmits at least one activatesignal to the at least one delivery circuit DELIVERY(1) to DELIVERY(N)to dispense at least one dose of the medication.

FIGS. 16A and 16B are flow diagrams of example processes 1500, 1550 toadminister multiple doses of medication from a self-administratingmedication applicator. Processes 1500, 1550 utilize a bi-directionalcommunication link between the activation circuitry 1400 and at leastone of the mobile device 120, the server, and the medical monitoringhub.

Referring to FIG. 16A, at the start of process 1500 a counter m can beinitialized to zero. At step 1505, the activation circuitry 1400receives an alarm signal indicting an overdose event. At step 1505, thecounter is incremented. At step 1515, the processing circuitry 1402transmits activation signal to the delivery circuitry to deliver themedication to the user. At step 1520, the processing circuitry 1402determines whether all of the doses in the multi-doseself-administrating medication applicators 1100, 1200 have beenactivated. The count m can be compared to the number of doses N in theapplicator 1100, 1200. When there are doses remaining in the applicator1100, 1200 (m<N), the process 1500 returns to step 1505. When there areno more doses of the medication in the applicator 1100, 1200, (m=N),then the process 1500 moves to step 1525. At step 1525, the processingcircuitry 1402 transmits, via the transceiver 1404 and one or moreantenna 1414, a notification that the applicator 1100, 1200 is empty.

Referring to FIG. 16B, at process 1550, the activation circuitry 1400receives an alarm signal that an opioid event is occurring or will soonoccur. At step 1560, the processing circuitry 1402 transmits theactivate signal to one or more of the delivery circuitry 1410 to deliverthe medication to the user. At step 1465, the activation circuitry 1400transmits, via the transceiver 1404 and the one or more antenna 1414, anindication of the number of remaining doses in the applicator 1100,1200.

Patch with Pressurized Reservoir

FIG. 17 a schematic diagram of an example wearable self-administratingmedication applicator 1700 that includes an antenna, a reservoir 1710, aneedle 1712, a processor 1714, a sensor 1716, a battery 1718, a fabriclayer 1720, and an adhesive layer 1722. The self-administratingmedication application can be configured as a patch 1700 that is adheredto the user's skin by the adhesive layer 1722. The patch 1700 canprovide opioid overdose monitoring and administration of an opioidreceptor antagonist. The patch 1700 can be a single use, preloaded,disposable device.

The reservoir 1710 can include an opioid receptor antagonist, such asNaloxone which is dispensed via the needle 1712 into the user. Theneedle 1712 can be a microneedle. Sensor 1716 can be internal to thepatch 1700 and monitors the user's physiological parameters. Instead ofthe patch 1700 including an internal sensor 1716, an external sensor1717 can monitor the user's physiological parameters and can wirelesslycommunicate with the patch 1700 via the antennas. The external sensor1717 can be wired to the patch 1700 and provide the sensor data viawires. External sensor 1717 can be a finger sensor that wraps around orover a finger or a toe a Sensor 1716 or sensor 1718 can include pulseoximeters, respiratory monitors, and other sensor devices disclosedherein that monitor the user's physiological parameters. The processor1714 can process the sensor data to detect an overdose event. The patch1700 can transmit the sensor data to an external processing device, suchas a mobile device or a hub device for detection of an opioid overdoseevent.

The needle 1712 can be spring-loaded (e.g., in a switch-blade likemanner). Fabric layer 1720 can hold the spring-loaded needle 1712 in acompressed state without the spring-loaded needle puncturing the fabriclayer 1720. When an opioid overdose event is detected, the battery 1718can release a charge that passes through at least a portion of thefabric layer 1720. The fabric layer 1720 receives the electrical chargefrom the battery 1718, which can cause the fabric layer 1720 to burn orshrink and the spring-loaded needle to be no longer restrained. Theneedle 1712 releases and can inject the user with the opioid receptorantagonist, such as Naloxone, stored in the reservoir. The reservoir1710 can be pressurized to assist in the injection of the opioidreceptor antagonist when the needle is released. An external pump canpressurize the reservoir 1710. The patch 1700 can have no mechanicaltriggers. The battery 1718 can be sized to provide operating power forapproximately one week. The battery 1718 can be sized to provideoperating power for more than one week, more than two weeks, more thanone month, or greater periods of time.

Hub Based Opioid Monitoring System

FIG. 18A is a block diagram of an example opioid use monitoring system1800 that includes a sensor 1802, a delivery device 1804, a medicalmonitoring hub device 1806, and a network 1812, such as the Internethosting a cloud server, which can be considered a remote server becauseit is remote form the user. Sensor 1802 is configured to monitor theuser's physiological parameters and deliver device 1804 is configured todeliver a dose of an opioid receptor antagonist, such as Naloxone or thelike, when an opioid overdose event is detected. Sensor 1802 can be anoximetry device, respiration monitor, devices described herein to obtainthe user's physiological parameters, and the like. The sensor 1802 canbe an acoustic sensor, a capnography sensor or an impedance sensor tomonitor the user's respiration rate. The sensor 1802 can includes thesignal processing device 110 to process the raw sensor data.

Delivery device 1804 can be a self-administrating device, such asdevices 940, 950, 1100, 1200, 1700. The delivery device can be a devicethat is user or responder activated. The sensor 1802 can be internal tothe delivery device 1804. The sensor 1802 can be external to thedelivery device 1804.

The hub device 1806 can be configured to collect data and transmit thedata to a cloud server for evaluation. The hub device 1806 can comprisecommunications circuitry and protocols 1810 to communication with one ormore of the delivery device 1804, the sensor 1802, network 1812, mobilecommunication device 1818, such as a smart phone and the like, and otherdevices with monitoring capabilities 1816. Communications can beBluetooth or Wi-Fi, for example. The hub device 1806 can furthercomprise memory for data storage 1807, memory for application software1808, and a processor 1809. The application software can include areminder to put on the patch before sleeping. The hub device 1806 ispowered by AC household current and includes battery backup circuitry1818 for operation when the power is out. The hub device 1806 can bepowered through a USB port, using a charger connected to an AC outlet orconnected to an automobiles USB charging port. The hub device 1806 canannunciate a battery-low condition.

The hub device 1806 can be a Radius-7® by Masimo, Irvine, Calif. The hub1806 can comprise at least the memory for data storage 1807 and thebattery backup circuitry 1818 can physically interface and communicatewith the Radius-7®. The hub device 1806 can interface with the phonecradle of the Radius-7®.

The sensor 1802 can monitor the user's physiological parameters andtransmit the raw sensor data to the delivery device 1804, via wired orwireless communication. Optionally, the sensor 1802 can transmit the rawsensor data to the hub device 1806, via wired or wireless communication.The delivery device 1804 can process the raw sensor data to determinewhen an opioid overdose event occurs. The hub device 1806 can processthe raw sensor data to determine when an opioid overdose event occur.The hub device 1806 can transmit the raw sensor data to a cloud serverfor processing to determine when an opioid overdose event occurs. Whenan opioid overdose event is imminent or occurring, the cloud server cantransmit to the delivery device 1804 via the hub device 1806instructions to activate and deliver the opioid receptor antagonist,such as Naloxone. The cloud server can further transmit messages tocontacts 1814, such as friends, family emergency personnel, caregivers,police, ambulance services, other addicts, hospitals and the like. Thehub device 1806 can send the delivery device 1804 instructions toactivate.

It is important to avoid false-positive indications of an overdoseevent. Users may not wear the self-administrating delivery device 1804if the user experiences delivery of the opioid receptor antagonist whenan overdose event is not occurring or imminently going to occur. Toavoid false-positive indications, the wearable delivery device 1804 caninduce pain before administrating the opioid receptor antagonist when anoverdose event is detected to inform the user that the antagonist willbe administered. The wearable delivery device 1804 can provide electricshocks to the user to induce pain. The induced pain can escalate until athreshold is reached. The user can employ a manual override to indicatethat the user is conscious and not in need of the opioid receptorantagonist. The override can be a button, switch, or other user input onthe delivery device 1804, the mobile communication device 722 and/or thehub device 1806. The delivery device 1804, the mobile communicationdevice 722 and/or the hub device 1806 can wait for the user input for aperiod of time before triggering the release of the opioid receptorantagonist to avoid false-positive indications. The period of time canbe less than 1 minute, less than 5 minutes, less than 10 minutes,between 1 minute and 5 minutes, between 1 minute and 10 minutes, and thelike.

The memory for data storage 1807 can store the raw sensor data. Thememory for data storage can act as a “black box” to record data from aplurality of sources. It is critical to administer the opioid receptorantagonist to a user as soon as an opioid overdose event is detected.The opioid overdose event can be cessation of respiration or anindication that respiration will soon cease. The administration can beby a responder, such as a friend or emergency personnel, by aself-administrating device worn by the user, or by the user. To avoidmissing any signs that lead to an opioid overdose event, the hub device1806 can receive data from any devices with a monitoring capability. Forexample, many homes have household cameras which provide a video feed.Cell phones can provide text messages and also include microphones torecord voice. The cell phone or smart phone can be configured to listento breathing and transmit the breathing data. Intelligent personalassistants, such as Amazon's Alexa® controlled Echo speaker, Google'sGoogle Assistant®, Apple's Siri®, and the like, for example, alsoinclude microphones and have the ability to interface with the Internet.Many household appliances, such as refrigerators, washing machines,coffee makers, and the like, include Internet of Things technology andare also able to interface with the Internet. Medical monitoring devicesthat are being used by the opioid user for medical conditions, such asECG's may also provide additional data. Data from one or more of thesedevices can be stored in the memory 1807 and used by the hub device 1806or sent to the cloud server and used by the cloud server to detect anopioid overdose event. The hub device 1806 can determine what monitoringand Internet-connected devices are available and connect wirelessly tothe available monitoring and Internet connected devices to receive data.

The hub device 1806 can interface with an internet filter, such as aCircle® internet filter that connects to a home network to monitorcontent. The hub device 1806 can determine which network data isdirected to the user's well-being and store the well-being data.

The data can comprise text messages, voice recordings, video, and thelike. Because of privacy concerns, the hub device 1806 can determinewhich small portions of data are helpful to determining the user'sphysical condition and store only those portion of data.

Because devices can fail to connect to the Internet, it is important tohave redundant systems to report the sensor data for overdose detection.In the event that the hub device 1806 fails to connect to the Internet1812, the mobile device or other internet-connected devices found in thehome can provide an internet connection. For example, the hub device1806 can transmit the sensor data to the mobile device 1818 and themobile device 1818 can transmit the sensor data to the cloud server forprocessing. The sensor 1802 or delivery device 1804 can communicate withthe mobile device 1818 when the hub device to Internet connection fails.Intelligent personal assistants and IoT devices can also provideredundant (backup) internet communication. The hub device 1806 canannunciate when its internet connection fails.

The mobile device 1818 can monitor respiration rate, SPO2, or ECG inparallel with the sensor 1802 and hub device 1806 monitoring of theuser's physiological parameters to increase the likelihood that animminent overdose will be detected. The sensor 1802 can monitor theconcentration of an opioid in the user's bloodstream. The measuredconcentration can be a factor in determining an opioid overdose event toreduce instances of false positives.

A home security monitoring system can include the hub device 1806 and ahome security company can monitor the user's health via the hub device1806 and sensor 1802.

The opioid overdose monitoring application can be integrated intointelligent personal assistants, such as Amazon's Alexa®, for example.

The delivery device 1804 can include medication to induce vomiting. Theopioid user can ingest the vomit-inducing medication, if desired, toregurgitate any opioid substance remaining in the user's stomach. Thedelivery device 1804 can include reservoirs containing thevomit-inducing medication and a position-sensing sensor. Thevomit-inducing medication can be automatically dispensed after receivingsensor input indicating that the user is in an upright position.

The position-sensing sensor can monitor the user's movements todetermine that the user is upright. The delivery device 1804 can includeone or more sensors configured to obtain position, orientation, andmotion information from the user. The one or more sensors can include anaccelerometer, a gyroscope, and a magnetometer, which are configured todetermine the user's position and orientation in three-dimensionalspace. The delivery device 1804 or the hub device 1806 can be configuredto process the received information to determine the position of theuser.

FIG. 19 illustrates an example hub device 1900 of the opioid overdosemonitoring system of FIG. 18A. FIG. 18B is a flow diagram of a process1850 to administer the opioid receptor antagonist using the system ofFIG. 18A. At block 1852, the sensor 1802 can collect raw sensor datathat comprises physiological data. The sensor 1802 can transmit the rawsensor data to the delivery device 1804 and the delivery device 1804 cantransmit the raw sensor data to the hub device 1806. Alternately, thesensor 1802 can transmit the raw sensor data to the hub device 1806.

At block 1854, the hub device 1806 can store the raw sensor data. Atblock 1856, the hub device 1806 can collect and store data associatedwith the user's well-being from other devices local to the user. Forexample, the hub device can receive data from one or more home cameras,data from microphones and cameras of intelligent home assistants, suchas Alexa®, for example, internet data from a home internet filter, andthe like.

At block 1858, the hub device 1806 can transmit via the network 1812,the stored data to a cloud server for processing. The cloud server canprocess the data to determine whether an opioid overdose event isoccurring or will be imminent. At block 1860, the hub device 1806 canreceive from the cloud server an indication that an opioid overdoseevent is occurring or imminent. The hub device 1806 can transmit theindication to the delivery device 1804.

At block 1862, the delivery device 1804 can provide the user withescalating actions to prompt the user to activate a manual override toindicate that the opioid overdose event is not occurring. For example,the delivery device can provide increasing electric shocks to the user,up to a threshold.

At block 1864, the delivery device 1804 can determine whether anoverride from the user has been received. When an override is indicated,such as from a user activated button or switch on the delivery device1804, the process 1850 returns to block 1852 to continue collectingphysiological parameters. When an override is not indicated, the process1850 moves to block 1866. At block 1866, the delivery device 1804administers the medication, such as Naloxone or other opioid receptorantagonist and returns to block 1852 to continue monitoring thephysiological parameters.

FIGS. 18A1-18A25 illustrate various example software applications totrigger an alarm and notify a friend when an opioid overdose isindicated. The software application can be downloaded onto the user'ssmart mobile device 1818.

FIG. 18A1 is an example screenshot illustrating a welcome message to anew user of the opioid overdose monitoring application. The illustratedscreenshot of FIG. 18A1 displays an illustration of a hand wearing anexample sensor and signal processing device 1802. The user can create anaccount for the overdose monitoring application. Once accountregistration is successful, the example application 1808 can instructthe user to set up the communications between the mobile device 1818,the sensor and signal processing device 1802, the medical monitoring hubdevice 1806, and the home Wi-Fi network.

FIG. 18A2 is an example screenshot illustrating instructions to the userto power the medical monitoring hub device 1806 to wireless connect tothe mobile device 1818. For example, the medical monitoring hub device1806 can be Bluetooth enabled. FIG. 18A3 is an example screenshotillustrating that the medical monitoring hub device 1806 is successfullyconnected.

FIGS. 18A4-18A6 are example screenshots illustrating instructions topower the sensor and signal processing device 1802 in order towirelessly connect to the medical monitoring hub device 1806. Theillustrated screenshot of FIG. 18A4 displays an illustration of thesignal processing portion of the sensor and signal processing device1802 in an open state to receive an integrated circuit (“chip”). Theillustrated screenshot of FIG. 18A5 displays an illustration of thesignal processing portion of the sensor and signal processing device1802 in a closed state. The illustrated screenshot of FIG. 18A6 displaysan illustration of the sensor portion of the sensor and signalprocessing device 1802 in a powered state.

FIG. 18A7-18A8 is are example screenshots illustrating instructions topair the powered sensor and signal processing device 1802 with themedical monitoring hub device 1806. For example, the sensor and signalprocessing device 1802 can be Bluetooth enabled.

The user can allow the software application to access Wi-Fi settings fora router on a local network, such as a home network. The user can accessthe Wi-Fi hub setup and choose a network from a list of availablenetworks local to the user. The illustrated screenshot of FIG. 18A9 isan example screenshot displaying an indication that the medicalmonitoring hub device 1806 is connecting to the local network.

FIG. 18A10 is an example screenshot asking the user to allow thesoftware application to access location information. When the softwareapplication has access to the user's location information such as thelocation information found on the user's mobile device 1818, thesoftware application can provide the user's location to emergencypersonnel, caregivers, friends, and family, etc. when they are notifiedof an overdose event.

FIG. 18A11 is an example screenshot displaying an indication that themedical monitoring hub device 1806 is connecting to the cloud server1812 via the local network. After the setup is complete, the medicalmonitoring hub device 1806 can communicate with the sensor and signalprocessing device 1802, the mobile device 1818 running the softwareapplication, and the could server 1812.

FIG. 18A12 is an example screenshot displaying a prompt to the user toadd contact information for the respondents to be notified of an opioidoverdose event that is occurring or will soon occur, the user canselect, for example, from the list of contacts found in the mobiledevice 1818.

FIG. 18A13 is an example screenshot illustrating a selected respondentto be notified in the event of an opioid overdose event, where theopioid overdose event can be an overdose that is presently occurring or,based on the user's physiological parameters sensed by the sensor andsignal processing device 1802, will soon occur. The selected respondentcan also be notified of situations that may cause the opioid monitoringsystem to fail if not corrected, such as when the user is not wearingthe sensor or the sensor battery is low. The illustrated screenshot ofFIG. 18A13 displays the selected respondent's name and phone number andprovides a selection of alerts that the user can choose the respondentto receive. The example selections include a parameter alert, a sensoroff alert, and a battery low alert. The parameter alert can be sent whenthe monitored physiological parameter falls outside a range ofacceptable values. The sensor off alert can be sent when the user is notwearing the sensor and signal processing device 1802. The batter lowalert can be sent when the battery voltage in the sensor and signalprocessing device 1802 fall below a threshold value.

FIG. 18A19 is an example screenshot illustrating a selection ofparameter notifications to be sent to the selected respondent. In theillustrated screenshot of Figure A19, the user can select to send therespondent any combination of a red alarm, an orange alarm, and a yellowalarm. For example, for the oxygen saturation parameter, a red alarm canbe sent when the user's oxygen saturation falls within the range of0-88; an orange alarm can be sent when the user's oxygen saturationfalls within the range of 89-90, and a yellow alarm can be sent when theuser's oxygen saturation falls within the range of 91-95 to provide anindication of the severity of the overdose event to the respondent.

FIGS. 18A14-18A15 are example screenshots illustrating the real timemonitoring of the user's physiological parameters. The illustratedscreenshots of FIGS. 18A14-18A15 display representation of dialsindicating the monitored oxygen saturation, heart rate in beats perminute, and perfusion index. The illustrated screenshot of FIG. 18A14indicates that the monitored oxygen saturation (96), heart rate 102),and perfusion index (8.5) are acceptable values. The illustratedscreenshot of FIG. 18A15 indicates that the monitored oxygen saturation(86) is no longer within an acceptable range.

FIG. 18A16 is an example screenshot displaying a warning message to theuser that the sensor is disconnected.

FIG. 18A17 is an example screenshot illustrating historical averages ofthe user's monitored physiological parameters. The illustratedscreenshot of FIG. 18A17 displays the average oxygen saturation, heartrate, and perfusion index for the period of time the sensor and signalprocessing device 1802 collected data for two dates, March 11, and March12.

FIG. 18A18 is an example screenshot illustrating session data for oxygensaturation, heart rate, and perfusion index on March 7. The displayedinformation in the illustrated example includes the minimum, maximum andaverage of the monitored physiological parameter.

FIG. 18A20 is an example screenshot illustrating sound options availablefor the software application. In the illustrated screenshot of FIG.18A20, the software application can cause the mobile device 1818 to playa sound, such as a beep, that coincides with the user's pulse, play asound, such as a beep, when a measurement value breaches its thresholdrange, and play a beep sound even when the software application isrunning in the background.

FIG. 18A21 is an example screenshot illustrating customizable alarmvalues. Some users may have a higher tolerance for opioids and an opioidevent may not be occurring when the user's physiological parameters fallwithin a range that typically signals an opioid overdose event. It isdesirable to avoid false alarms that may desensitize respondents tonotifications. In the illustrated screenshot of FIG. 18A21, the rangesfor a red, orange, and yellow alarms for oxygen saturation can becustomized for the user by, for example, sliding the indicators alongthe green-yellow-orange-red bar until the desired values are displayed.Selecting beats/minute and pleth variability permits the user tocustomize the alarm ranges for heart rate and perfusion index,respectively.

FIG. 18A22 is an example screenshot illustrating that the user'sphysiological parameter data can be shared with other health monitoringapplications, such as Apple Health.

FIG. 18A23 is an example screenshot illustrating a reminder to put onthe sensor and signal processing device 1802 before going to bed. Thesoftware application may provide other reminders, such as time toreplace the sensor battery, turn on notifications, and the like.

FIGS. 18A24-18A25 are example screenshots illustrating a request foruser input when the user's physiological parameters indicate an opioidoverdose event is occurring or will soon occur. To avoid sending falsealarms, the software application requests user input to confirm that theuser is not unconscious or otherwise does not want alarm notificationsto be send to respondents. In the illustrated screenshot of FIG. 18A24,the user is asked to swipe the screen to confirm safety. In theillustrated screenshot of FIG. 18A25, the user is asked to enter anillustrated pattern on the screen to confirm safety. Different userinputs can be used to confirm different cognitive abilities of the user.For example, it is more difficult to enter the illustrated pattern ofFIG. 18A25 than to swipe the bottom of the screen in FIG. 18A24.

Opioid Monitoring Kits

FIGS. 20A and 20B are schematic diagrams of example prescription andnon-prescription opioid overdose monitoring kits 2000 and 2050. FIG. 20Ais an example of the opioid overdose monitoring kit 2000 that may beavailable by prescription only, per the applicable state or country law.Kit 2000 can comprise a hub device 1806, a sensor 102, 610-640, 1802,and a delivery device 940, 950, 1100, 1200, 1702 that includes one ormore doses of an opioid receptor antagonist receptor, such as Naloxone.FIG. 20B is an example of the opioid overdose monitoring kit 2050 thatmay be available without a prescription. Kit 2050 can comprise the hubdevice 1806 and a sensor 102, 610-640, 1802. Kits 2000, 2050 may includeadditional components to assist in opioid overdose monitoring.

Other Delivery Methods/Mechanisms

As discussed herein, opioid receptor antagonists can be delivered byintravenous injection, intramuscular injection, and intranasalapplication, where a liquid form of the medication is sprayed into theuser's nostrils. Administration of the medication can also occur via anendotracheal tube, sublingually, where a gel or tablet of the medicationis applied under the tongue, and transdermally, where the medication canbe a gel applied directly to the skin or within a transdermal patchapplied to the skin.

Other methods of administrating the opioid receptor antagonist can bevia rectal capsule or suppository. The capsule can also monitorrespiration rate and/or pulse rate and rupture the capsule when anopioid overdose event is imminent or occurring. A Bluetooth® signal canactivate the capsule.

The opioid receptor antagonist can be included in an inhaler, by firstinjecting the user with an antiseptic and then with the opioid receptorantagonist, or in administered in an ear or other body orifice. Theopioid receptor antagonist can be delivered through a cannula for aventilator or breathing machine, for example.

The opioid receptor antagonist can be stored in a dental retainer thatis crushed to release the stored drug.

An implantable delivery device can deliver the opioid receptorantagonist for chronic opioid users. The device can be implanted in asimilar location as a pacemaker. The device can monitor one or more ofrespiration rate, pulse rate, ECG and SPO2 and release a dose of opioidreceptor antagonist when an opioid overdose event is detected. Theimplantable device can comprise multiple doses and/or can be refillableby injecting the opioid receptor antagonist into the implantabledelivery device. Such as delivery device can be implanted for one ormore months. Another example of an implantable delivery device comprisesa capsule containing the opioid receptor antagonist and an externaldevice, such as a strap over the capsule that transmits a resonantfrequency. The resonant frequency causes the capsule to rupture and thereleased opioid receptor antagonist is absorbed by the body.

The opioid receptor antagonist is contained in a pill that is activatedwhen needed. The opioid receptor antagonist can be encased in a gel packthat is ingested or worn on the skin. An ultrasonic device, worn as awrist strap, for example, can rupture the gel pack, adhered to the skin,for example, when an opioid overdose event is detected. The body canabsorb the opioid receptor antagonist from the ruptured gel pack.

Terminology

The embodiments disclosed herein are presented by way of examples onlyand not to limit the scope of the claims that follow. One of ordinaryskill in the art will appreciate from the disclosure herein that manyvariations and modifications can be realized without departing from thescope of the present disclosure.

The term “and/or” herein has its broadest least limiting meaning whichis the disclosure includes A alone, B alone, both A and B together, or Aor B alternatively, but does not require both A and B or require one ofA or one of B. As used herein, the phrase “at least one of” A, B, “and”C should be construed to mean a logical A or B or C, using anon-exclusive logical or.

The description herein is merely illustrative in nature and is in no wayintended to limit the disclosure, its application, or uses. For purposesof clarity, the same reference numbers will be used in the drawings toidentify similar elements. It should be understood that steps within amethod may be executed in different order without altering theprinciples of the present disclosure.

As used herein, the term module may refer to, be part of, or include anApplication Specific Integrated Circuit (ASIC); an electronic circuit; acombinational logic circuit; a field programmable gate array (FPGA); aprocessor (shared, dedicated, or group) that executes code; othersuitable components that provide the described functionality; or acombination of some or all of the above, such as in a system-on-chip.The term module may include memory (shared, dedicated, or group) thatstores code executed by the processor.

The term code, as used above, may include software, firmware, and/ormicrocode, and may refer to programs, routines, functions, classes,and/or objects. The term shared, as used above, means that some or allcode from multiple modules may be executed using a single (shared)processor. In addition, some or all code from multiple modules may bestored by a single (shared) memory. The term group, as used above, meansthat some or all code from a single module may be executed using a groupof processors. In addition, some or all code from a single module may bestored using a group of memories.

The apparatuses and methods described herein may be implemented by oneor more computer programs executed by one or more processors. Thecomputer programs include processor-executable instructions that arestored on a non-transitory tangible computer readable medium. Thecomputer programs may also include stored data. Non-limiting examples ofthe non-transitory tangible computer readable medium are nonvolatilememory, magnetic storage, and optical storage. Although the foregoinginvention has been described in terms of certain preferred embodiments,other embodiments will be apparent to those of ordinary skill in the artfrom the disclosure herein. Additionally, other combinations, omissions,substitutions and modifications will be apparent to the skilled artisanin view of the disclosure herein. Accordingly, the present invention isnot intended to be limited by the reaction of the preferred embodiments,but is to be defined by reference to claims.

Conditional language used herein, such as, among others, “can,” “might,”“may,” “e.g.,” and the like, unless specifically stated otherwise, orotherwise understood within the context as used, is generally intendedto convey that certain embodiments include, while other embodiments donot include, certain features, elements and/or states. Thus, suchconditional language is not generally intended to imply that features,elements and/or states are in any way required for one or moreembodiments or that one or more embodiments necessarily include logicfor deciding, with or without author input or prompting, whether thesefeatures, elements and/or states are included or are to be performed inany particular embodiment. The terms “comprising,” “including,”“having,” and the like are synonymous and are used inclusively, in anopen-ended fashion, and do not exclude additional elements, features,acts, operations, and so forth. Also, the term “or” is used in itsinclusive sense (and not in its exclusive sense) so that when used, forexample, to connect a list of elements, the term “or” means one, some,or all of the elements in the list. Further, the term “each,” as usedherein, in addition to having its ordinary meaning, can mean any subsetof a set of elements to which the term “each” is applied.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the devices or algorithms illustrated can be madewithout departing from the spirit of the disclosure. As will berecognized, certain embodiments of the inventions described herein canbe embodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others.

Additionally, all publications, patents, and patent applicationsmentioned in this specification are herein incorporated by reference tothe same extent as if each individual publication, patent, or patentapplication was specifically and individually indicated to beincorporated by reference.

What is claimed is:
 1. A system to monitor a user for an opioid overdoseevent, the system comprising software instructions storable on a memoryof a mobile computing device that includes one or more hardwareprocessors, wireless communication circuitry, a touchscreen display, aspeaker, a camera, and a microphone, the software instructions causingthe one or more hardware processors to: receive representations ofimages from the camera; process the representations of images todetermine respiratory distress; determine an opioid overdose event isoccurring or will soon occur based on the processed representations ofthe images; present a request for user input on the touchscreen displaybased on the determination; generate an escalating alarm with thespeaker based on the determination to prompt the user to provide theuser input; and transmit wirelessly notifications of the opioid overdoseevent to one or more recipients based on a failure to receive the userinput.
 2. The system of claim 1 wherein the one or more hardwareprocessors are further configured to receive representations of soundsfrom the microphone of the mobile computing device, and determine theopioid overdose event is occurring or will soon occur based on thereceived representations of the sounds and images.
 3. The system ofclaim 1 wherein the one or more hardware processors are furtherconfigured to: receive monitoring data from a monitoring service thatmonitors the user and an environment local to the user; and transmit thenotification of the opioid overdose event to the monitoring service. 4.The system of claim 3 wherein the monitoring data includes user dataassociated with a state of the user and environmental data associatedwith the environment local to the user.
 5. The system of claim 1 whereinthe one or more recipients include friends and family having contactinformation stored in the memory of the mobile computing device.
 6. Thesystem of claim 1 wherein the notifications include directions to alocation of the mobile computing device.
 7. The system of claim 1wherein the one or more hardware processors further analyze therepresentations of the sounds from the microphone to determinerespiratory distress of the user.
 8. The system of claim 1 wherein theone or more processors further cause the touchscreen display to displaycare instructions to care for a victim of an opioid overdose.
 9. Thesystem of claim 1 wherein the mobile computing device further comprisesa speaker and the one or more hardware processors further cause thespeaker to output an audible alarm based on the determination.
 10. Thesystem of claim 1 wherein the one or more hardware processors furthercause the touchscreen display to flash, cause the touchscreen display todisplay directions to a location of the mobile computing device, orcause a speaker of the mobile computing device to provide audibledirections to the location of the mobile computing device.
 11. A systemto monitor a user for an opioid overdose event, the system comprising:one or more sensors configured to sense one or more physiologicalparameters associated with respiration of a user from an environmentlocal to the user and provide raw sensor data for the sensed one or morephysiological parameters; a signal processing device in communicationwith the one or more sensors, the signal processing device configured toreceive the raw sensor data from the one or more sensors and process theraw sensor data to determine respiration data; and a mobile computingdevice in communication with the signal processing device, the mobilecomputing device comprising wireless communication circuitry, atouchscreen display, a speaker, a camera, memory storing softwareinstructions, and one or more hardware processors configured to executethe software instructions to at least: receive the respiration data fromthe signal processing device; determine a respiration rate based on therespiration data; receive representations of images of a user from thecamera; process, with one or more hardware processors, therepresentations of the images to determine respiratory distress; for thedetermined respiration rate less than a threshold, determine, with theone or more hardware processors, an opioid overdose event is occurringor will soon occur based on the processed representations of the images;present a request for user input on the touchscreen display based on thedetermination of the opioid overdose event; generate an escalating alarmwith the speaker based on the request for user input to prompt the userto provide the user input; and transmit wirelessly notifications of thedetermined overdose event to one or more recipients based on a failureto receive the user input.
 12. The system of claim 11 wherein the one ormore hardware processors are further configured to: receive monitoringdata from a monitoring service that monitors the user and an environmentlocal to the user; and transmit the notification of the opioid overdoseevent to the monitoring service.
 13. The system of claim 11 wherein thenotifications include one or more of a text message, a phone call, andan email.
 14. The system method of claim 11 wherein the one or morehardware processors further analyze representations of sounds from amicrophone of the mobile computing device to determine the respiratorydistress of the user.
 15. The system method of claim 11 wherein the oneor more hardware processors further analyze the representations of theimages from the camera to determine an unconscious state of the user.16. The system of claim 11 wherein the one or more hardware processorsfurther cause the touchscreen display to flash, cause the touchscreendisplay to display directions to a location of the mobile computingdevice, or cause the speaker to provide audible directions to thelocation.
 17. A method to monitor a user for an opioid overdose event,the method comprising: receiving representations of images of a userfrom a camera of a mobile computing device; processing, with one or morehardware processors of the mobile computing device, the representationsof images to determine respiratory distress; determining, with the oneor more hardware processors of the mobile computing device, an opioidoverdose event is occurring or will soon occur based on the processedrepresentations of the images; presenting, with the one or more hardwareprocessors of the mobile computing device, a request for user input on atouchscreen display of the mobile computing device, the request based onthe determination; generating an escalating alarm with a speaker of themobile computing device based on the determination to prompt the user toprovide the user input; and transmitting wirelessly, with the mobilecomputing device, notifications of the overdose event to one or morerecipients based on a failure to receive the user input.
 18. The methodof claim 17 further comprising: receive monitoring data from amonitoring service that monitors the user and an environment local tothe user; and transmit the notification of the opioid overdose event tothe monitoring service.
 19. The method of claim 17 further comprisinganalyzing representations of sounds from a microphone of the mobilecomputing device to determine respiratory distress of the user.
 20. Thesystem method of claim 17 wherein the one or more hardware processorsfurther analyze the representations of the images from the camera todetermine an unconscious state of the user.